Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported January 24, 2024
Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers ROL B FOR VLT400SF STP - ARDROL309001A, ROL B FOR VLT400SF STP - ARDROL309001C, ROL B FOR VLT600SF STP - ARDROL309003A, ROL B FOR VLT600SF STP - ARDROL309003C, ROL FOR VLT400SF STP - ARDROL309000A, ROL FOR VLT400SF STP - ARDROL309000C, ROL FOR VLT600SF STP - ARDROL309002A, ROL FOR VLT600SF STP - ARDROL309002C, VCS40 ROL - ARDROL309024A, VCS40 ROL - ARDROL309024C, VCS40 ROL - ARDR
A potential for a light system to fall in the operating room.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Getinge Usa Sales Inc recalled Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model… - a moderate-severity action.
Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model… was recalled by Getinge Usa Sales Inc in January 24, 2024. Reason: A potential for a light system to fall in the operating room.. Check the official notice for the remedy. Verify recall #Z-0758-2024 with the FDA Devices before acting.
The recall
Getinge Usa Sales Inc issued this moderate-severity FDA Devices recall-A potential for a light system to fall in the operating room..
- Moderate
- severity level
- 237K units
- affected scope
- Class II
- classification
- January 24, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0758-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0758-2024) was formally reported on January 24, 2024, with the manufacturer initiating the action on November 8, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Getinge Usa Sales Inc is listed as the recalling firm, operating out of Wayne, NJ. Federal records list the affected scope as 236793 units in total, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: A potential for a light system to fall in the operating room. Distribution data in the federal record shows the product reached: US Nationwide. Global Distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
236793 units in total
Related Recalls
6
3 from same agency
Product description
Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers ROL B FOR VLT400SF STP - ARDROL309001A, ROL B FOR VLT400SF STP - ARDROL309001C, ROL B FOR VLT600SF STP - ARDROL309003A, ROL B FOR VLT600SF STP - ARDROL309003C, ROL FOR VLT400SF STP - ARDROL309000A, ROL FOR VLT400SF STP - ARDROL309000C, ROL FOR VLT600SF STP - ARDROL309002A, ROL FOR VLT600SF STP - ARDROL309002C, VCS40 ROL - ARDROL309024A, VCS40 ROL - ARDROL309024C, VCS40 ROL - ARDROL309028A, VCS40 ROL - ARDROL309028C, VCS60 ROL - ARDROL309025A, VCS60 ROL - ARDROL309025C, VCS60 ROL - ARDROL309029A, VCS60 ROL - ARDROL309029C, VST40 - ARDROL309016A, VST40 - ARDROL309016C, VST40 - ARDROL309017A, VST40 - ARDROL309017C, VST40 - ARDROL309020A, VST40 - ARDROL309020C, VST40 - ARDROL309022A, VST40 - ARDROL309022C, VST60 - ARDROL309018A, VST60 - ARDROL309018C, VST60 - ARDROL309019A, VST60 - ARDROL309019C, VST60 - ARDROL309021A, VST60 - ARDROL309021C, VST60 - ARDROL309023A, VST60 - ARDROL309023C, VCS40DF - ARDVCS209001A, VCS40DF - ARDVCS209001C, VCS40DF - ARDVCS209010A, VCS40DF - ARDVCS209012A, VCS40DF - ARDVCS209021A, VCS40SF - ARDVCS209000A, VCS40SF - ARDVCS209000C, VCS40SF - ARDVCS209011A, VCS40SF 08 - ARDVCS209046A, VCS44DF - ARDVCS209005A, VCS44DF - ARDVCS209005C, VCS44DF - ARDVCS209016A, VCS44SF - ARDVCS209004A, VCS44SF - ARDVCS209004C, VCS44SF - ARDVCS209015A, VCS44SFDF - ARD2VCS00040A, VCS60DF - ARDVCS209003A, VCS60DF - ARDVCS209003C, VCS60DF - ARDVCS209014A, VCS60DF - ARDVCS209022A, VCS60DF 11 - ARDVCS209047A, VCS60SF - ARDVCS209002A, VCS60SF - ARDVCS209002C, VCS60SF - ARDVCS209013A, VCS64DF - ARDVCS209007A, VCS64DF - ARDVCS209007C, VCS64DF - ARDVCS209018A, VCS64SF - ARDVCS209006A, VCS64SF - ARDVCS209006C, VCS64SF - ARDVCS209017A, VCS64SFDF - ARD2VCS00010A, VCS64SFDF 1011 - ARDVCS209048A, VCS66DF - ARDVCS209009A, VCS66DF - ARDVCS209009C, VCS66DF - ARDVCS209020A, VCS66SF - ARDVCS209008A, VCS66SF - ARDVCS209008C, VCS66SF - ARDVCS209019A, VCSII40DF SB08 - ARDVCS209023A, VCSII40DF SB11 - ARDVCS209024A, VCSII40SF SB11 - ARDVCS209025A, VCSII44DF SB0810 - ARDVCS209026A, VCSII44SF SB1011 - ARDVCS209027A, VCSII60DF SB08 - ARDVCS209028A, VCSII60SF SB11 - ARDVCS209029A, VCSII64DF SB0810 - ARDVCS209030A, VCSII64SF SB1011 - ARDVCS209031A, VCSII66DF SB0810 - ARDVCS209032A, VCSII66SF SB1011 - ARDVCS209033A, VCSII40DF TK SB08 - ARDVCS209034A, VCSII40DF TK SB11 - ARDVCS209035A, VCSII40SF TK SB11 - ARDVCS209036A, VCSII44DF TK SB0810 - ARDVCS209037A, VCSII44SF TK SB1011 - ARDVCS209038A, VCSII60DF TK SB08 - ARDVCS209039A, VCSII60SF TK SB11 - ARDVCS209040A, VCSII64DF TK SB0810 - ARDVCS209041A, VCSII64SF TK SB1011 - ARDVCS209042A, VCSII66DF TK SB0810 - ARDVCS209043A, VCSII66SF TK SB1011 - ARDVCS209044A, VCS40DF SAT 12 - ARD2VCS00070A, VCSII40SF SB08 - ARDVCS209049A, VCSII64SFDF SB1011 - ARDVCS209050A, SAT VLT400D - ARD2SAT00080C, SAT VLT400D - ARD2SAT00100C, SAT VLT400DF - ARD2SAT00080A, SAT VLT400DF - ARD2SAT00100A, SAT VLT400S - ARD2SAT00030C, SAT VLT400S - ARD2SAT00040C, SAT VLT400SF - ARD2SAT00040A, SAT VLT40DF - ARD268800130A, SAT VLT40DF - ARD268800130C, SAT VLT40SF - ARD268800120A, SAT VLT40SF - ARD268800120C, SAT VLT60DF - ARD2SAT00170A, SAT VLT60DF - ARD2SAT00170C, SAT VLT60SF - ARD2SAT00180C, SAT VST40DF - ARDSAT209018A, SAT VST40DF - ARDSAT209019A, SAT VST40DF - ARDSAT209022A, SAT VST40DF - ARDSAT209023A, SAT VST40SF - ARDSAT209010A, SAT VST40SF - ARDSAT209011A, SAT VST40SF - ARDSAT209014A, SAT VST40SF - ARDSAT209015A, SAT VST60DF - ARDSAT209034A, SAT VST60DF - ARDSAT209035A, SAT VST60DF - ARDSAT209038A, SAT VST60DF - ARDSAT209039A, SAT VST60SF - ARDSAT209026A, SAT VST60SF - ARDSAT209027A, SAT VST60SF - ARDSAT209030A, SAT VST60SF - ARDSAT209031A, STANDOP 40DF SINGLE - ARDSTP229005A, STANDOP 40SF SINGLE - ARDSTP229000A, STANDOP 44DF DOUBLE - ARDSTP229007A, STANDOP 44SF DOUBLE - ARDSTP229002A, STANDOP 60DF SINGLE - ARDSTP229006A, STANDOP 60SF SINGLE - ARDSTP229001A, STANDOP 64DF DOUBLE - ARDSTP229008A, STANDOP 64SF DOUBLE - ARDS
Reason for recall
A potential for a light system to fall in the operating room.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0758-2024 |
| Date reported | January 24, 2024 |
| Date initiated | November 8, 2023 |
| Recalling firm | Getinge Usa Sales Inc |
| Firm location | Wayne, NJ |
| Affected scope | 236793 units in total |
| Distribution | US Nationwide. Global Distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0758-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers ROL B FOR VLT400SF STP - ARDROL309001A, ROL B FOR VLT400SF STP - ARDROL309001C, ROL B FOR VLT600SF STP - ARDROL309003A, ROL B FOR VLT600SF STP - ARDROL309003C, ROL FOR VLT400SF STP - ARDROL309000A, ROL FOR VLT400SF STP - ARDROL309000C, ROL FOR VLT600SF STP - ARDROL309002A, ROL FOR VLT600SF STP - ARDROL309002C, VCS40 ROL - ARDROL309024A, VCS40 ROL - ARDROL309024C, VCS40 ROL - ARDROL309028A, VCS40 ROL - ARDROL309028C, VCS60 ROL - ARDROL309025A, VCS60 ROL - ARDROL309025C, VCS60 ROL - ARDROL309029A, VCS60 ROL - ARDROL309029C, VST40 - ARDROL309016A, VST40 - ARDROL309016C, VST40 - ARDROL309017A, VST40 - ARDROL309017C, VST40 - ARDROL309020A, VST40 - ARDROL309020C, VST40 - ARDROL309022A, VST40 - ARDROL309022C, VST60 - ARDROL309018A, VST60 - ARDROL309018C, VST60 - ARDROL309019A, VST60 - ARDROL309019C, VST60 - ARDROL309021A, VST60 - ARDROL309021C, VST60 - ARDROL309023A, VST60 - ARDROL309023C, VCS40DF - ARDVCS209001A, VCS40DF - ARDVCS209001C, VCS40DF - ARDVCS209010A, VCS40DF - ARDVCS209012A, VCS40DF - ARDVCS209021A, VCS40SF - ARDVCS209000A, VCS40SF - ARDVCS209000C, VCS40SF - ARDVCS209011A, VCS40SF 08 - ARDVCS209046A, VCS44DF - ARDVCS209005A, VCS44DF - ARDVCS209005C, VCS44DF - ARDVCS209016A, VCS44SF - ARDVCS209004A, VCS44SF - ARDVCS209004C, VCS44SF - ARDVCS209015A, VCS44SFDF - ARD2VCS00040A, VCS60DF - ARDVCS209003A, VCS60DF - ARDVCS209003C, VCS60DF - ARDVCS209014A, VCS60DF - ARDVCS209022A, VCS60DF 11 - ARDVCS209047A, VCS60SF - ARDVCS209002A, VCS60SF - ARDVCS209002C, VCS60SF - ARDVCS209013A, VCS64DF - ARDVCS209007A, VCS64DF - ARDVCS209007C, VCS64DF - ARDVCS209018A, VCS64SF - ARDVCS209006A, VCS64SF - ARDVCS209006C, VCS64SF - ARDVCS209017A, VCS64SFDF - ARD2VCS00010A, VCS64SFDF 1011 - ARDVCS209048A, VCS66DF - ARDVCS209009A, VCS66DF - ARDVCS209009C, VCS66DF - ARDVCS209020A, VCS66SF - ARDVCS209008A, VCS66SF - ARDVCS209008C, VCS66SF - ARDVCS209019A, VCSII40DF SB08 - ARDVCS209023A, VCSII40DF SB11 - ARDVCS209024A, VCSII40SF SB11 - ARDVCS209025A, VCSII44DF SB0810 - ARDVCS209026A, VCSII44SF SB1011 - ARDVCS209027A, VCSII60DF SB08 - ARDVCS209028A, VCSII60SF SB11 - ARDVCS209029A, VCSII64DF SB0810 - ARDVCS209030A, VCSII64SF SB1011 - ARDVCS209031A, VCSII66DF SB0810 - ARDVCS209032A, VCSII66SF SB1011 - ARDVCS209033A, VCSII40DF TK SB08 - ARDVCS209034A, VCSII40DF TK SB11 - ARDVCS209035A, VCSII40SF TK SB11 - ARDVCS209036A, VCSII44DF TK SB0810 - ARDVCS209037A, VCSII44SF TK SB1011 - ARDVCS209038A, VCSII60DF TK SB08 - ARDVCS209039A, VCSII60SF TK SB11 - ARDVCS209040A, VCSII64DF TK SB0810 - ARDVCS209041A, VCSII64SF TK SB1011 - ARDVCS209042A, VCSII66DF TK SB0810 - ARDVCS209043A, VCSII66SF TK SB1011 - ARDVCS209044A, VCS40DF SAT 12 - ARD2VCS00070A, VCSII40SF SB08 - ARDVCS209049A, VCSII64SFDF SB1011 - ARDVCS209050A, SAT VLT400D - ARD2SAT00080C, SAT VLT400D - ARD2SAT00100C, SAT VLT400DF - ARD2SAT00080A, SAT VLT400DF - ARD2SAT00100A, SAT VLT400S - ARD2SAT00030C, SAT VLT400S - ARD2SAT00040C, SAT VLT400SF - ARD2SAT00040A, SAT VLT40DF - ARD268800130A, SAT VLT40DF - ARD268800130C, SAT VLT40SF - ARD268800120A, SAT VLT40SF - ARD268800120C, SAT VLT60DF - ARD2SAT00170A, SAT VLT60DF - ARD2SAT00170C, SAT VLT60SF - ARD2SAT00180C, SAT VST40DF - ARDSAT209018A, SAT VST40DF - ARDSAT209019A, SAT VST40DF - ARDSAT209022A, SAT VST40DF - ARDSAT209023A, SAT VST40SF - ARDSAT209010A, SAT VST40SF - ARDSAT209011A, SAT VST40SF - ARDSAT209014A, SAT VST40SF - ARDSAT209015A, SAT VST60DF - ARDSAT209034A, SAT VST60DF - ARDSAT209035A, SAT VST60DF - ARDSAT209038A, SAT VST60DF - ARDSAT209039A, SAT VST60SF - ARDSAT209026A, SAT VST60SF - ARDSAT209027A, SAT VST60SF - ARDSAT209030A, SAT VST60SF - ARDSAT209031A, STANDOP 40DF SINGLE - ARDSTP229005A, STANDOP 40SF SINGLE - ARDSTP229000A, STANDOP 44DF DOUBLE - ARDSTP229007A, STANDOP 44SF DOUBLE - ARDSTP229002A, STANDOP 60DF SINGLE - ARDSTP229006A, STANDOP 60SF SINGLE - ARDSTP229001A, STANDOP 64DF DOUBLE - ARDSTP229008A, STANDOP 64SF DOUBLE - ARDS. Recalled by Getinge Usa Sales Inc. Units affected: 236793 units in total.
Why was this product recalled? ▼
A potential for a light system to fall in the operating room.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 24, 2024. Severity: Moderate. Recall number: Z-0758-2024.
Where was the recalled product distributed? ▼
Distribution: US Nationwide. Global Distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0758-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 24, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.