Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 31, 2022
Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 6881999 mobile cart)
Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Getinge Usa Sales Inc recalled Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory … - a moderate-severity action.
Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory … was recalled by Getinge Usa Sales Inc in August 31, 2022. Reason: Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipme…. Check the official notice for the remedy. Verify recall #Z-1568-2022 with the FDA Devices before acting.
The recall
Getinge Usa Sales Inc issued this moderate-severity FDA Devices recall-Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipme….
- Moderate
- severity level
- Class II
- classification
- August 31, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1568-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1568-2022) was formally reported on August 31, 2022, with the manufacturer initiating the action on July 21, 2022. 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 US 102 units; OUS 13750 units.
The documented reason for this recall is: Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used on the floor or on a table shall be per… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Australia (AU), Brazil (BR), China (CN), Egypt (EG), EEA, Hong Kong (HK), Israel (IL), Japan (JP), Mexico (MX), Pakistan (PK), Saudi Arabia (SA), South Africa …. 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
US 102 units; OUS 13750 units
Related Recalls
6
3 from same agency
Product description
Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 6881999 mobile cart)
Reason for recall
Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used on the floor or on a table shall be permanently marked with a clearly legible warning of this risk
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1568-2022 |
| Date reported | August 31, 2022 |
| Date initiated | July 21, 2022 |
| Recalling firm | Getinge Usa Sales Inc |
| Firm location | Wayne, NJ |
| Affected scope | US 102 units; OUS 13750 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia (AU), Brazil (BR), China (CN), Egypt (EG), EEA, Hong Kong (HK), Israel (IL), Japan (JP), Mexico (MX), Pakistan (PK), Saudi Arabia (SA), South Africa (ZA), South Korea (K… |
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-1568-2022) 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? ▼
Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 6881999 mobile cart). Recalled by Getinge Usa Sales Inc. Units affected: US 102 units; OUS 13750 units.
Why was this product recalled? ▼
Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used on the floor or on a table shall be permanently marked with a clearly legible warning of this risk
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 31, 2022. Severity: Moderate. Recall number: Z-1568-2022.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and the countries of Australia (AU), Brazil (BR), China (CN), Egypt (EG), EEA, Hong Kong (HK), Israel (IL), Japan (JP), Mexico (MX), Pakistan (PK), Saudi Arabia (SA), South Africa (ZA), South Korea (KR), Switzerland (CH), Taiwan (TW), Turkey (TR), and United Arab Emirates (AE)..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1568-2022) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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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 August 31, 2022. 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.