Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 23, 2018
Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751. Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals. The lACS obtains the physiologic, multi-parameter data from the connection
Software anomaly resulting in the loss of patient settings and stored patient data.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Draegar Medical Systems, Inc. recalled Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, … - a moderate-severity action.
Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, … was recalled by Draegar Medical Systems, Inc. in May 23, 2018. Reason: Software anomaly resulting in the loss of patient settings and stored patient data.. Check the official notice for the remedy. Verify recall #Z-1813-2018 with the FDA Devices before acting.
The recall
Draegar Medical Systems, Inc. issued this moderate-severity FDA Devices recall-Software anomaly resulting in the loss of patient settings and stored patient data..
- Moderate
- severity level
- Class II
- classification
- May 23, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1813-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1813-2018) was formally reported on May 23, 2018, with the manufacturer initiating the action on March 28, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Draegar Medical Systems, Inc. is listed as the recalling firm, operating out of Andover, MA. Federal records list the affected scope as 25, 629.
The documented reason for this recall is: Software anomaly resulting in the loss of patient settings and stored patient data. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and to the countries of : Angola, Argentina, Australia Austria Azerbaijan Bahrain Belgium Bolivia Brazil Brunei Dar-es-S Canada Chile China Colombia Costa Rica Czec…. 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
25, 629
Related Recalls
6
3 from same agency
Product description
Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751. Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The M540 is intended to monitor one patient at a time.
Reason for recall
Software anomaly resulting in the loss of patient settings and stored patient data.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1813-2018 |
| Date reported | May 23, 2018 |
| Date initiated | March 28, 2018 |
| Recalling firm | Draegar Medical Systems, Inc. |
| Firm location | Andover, MA |
| Affected scope | 25, 629 |
| Distribution | Worldwide Distribution - USA (nationwide) and to the countries of : Angola, Argentina, Australia Austria Azerbaijan Bahrain Belgium Bolivia Brazil Brunei Dar-es-S Canada Chile China Colombia Costa Rica Czech Republic Denmark … |
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-1813-2018) 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? ▼
Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751. Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The M540 is intended to monitor one patient at a time.. Recalled by Draegar Medical Systems, Inc.. Units affected: 25, 629.
Why was this product recalled? ▼
Software anomaly resulting in the loss of patient settings and stored patient data.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 23, 2018. Severity: Moderate. Recall number: Z-1813-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and to the countries of : Angola, Argentina, Australia Austria Azerbaijan Bahrain Belgium Bolivia Brazil Brunei Dar-es-S Canada Chile China Colombia Costa Rica Czech Republic Denmark Egypt Finland France Germany Ghana Greece Hong Kong Hungary India Indonesia Ireland Italy Japan Jordan Kenya Kuwait Latvia Liechtenstein Lithuania Macedonia Malaysia Maldives Mexico Monaco Mozambique Namibia Netherlands New Zealand Norway Pakistan Panama Peru Poland Portugal Qatar Reunion Russian Fed. Saudi Arabia Singapore Slovenia South Africa South Korea Spain Sweden Switzerland Thailand Trinidad &Tobago Turkey Turkmenistan United Kingdom USA Utd.Arab.Emir. Vietnam.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1813-2018) 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 May 23, 2018. 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.