FDA Devices recall · Reported May 8, 2013
Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respiratory failure or insufficiency. The ventilator is equipped with at least 2, NiMH battery modules (Part No. 6487180) which automatically supply 12V DC Power in case of an AC power failure, ensuring that ventilator settings
When using the SERVO-i on battery power, in a very small number of cases, some battery modules distributed after January 31, 2010 have a shorter battery run time than expected.
Maquet Cardiovascular Us Sales, Llc recalled Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part… - a critical-severity action.
Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part… was recalled by Maquet Cardiovascular Us Sales, Llc in May 8, 2013. Reason: When using the SERVO-i on battery power, in a very small number of cases, some battery modules distributed af…. Check the official notice for the remedy. Verify recall #Z-1177-2013 with the FDA Devices before acting.
The recall
Maquet Cardiovascular Us Sales, Llc issued this critical-severity FDA Devices recall-When using the SERVO-i on battery power, in a very small number of cases, some battery modules distributed af….
- Critical
- severity level
- 90K units
- affected scope
- Class I
- classification
- May 8, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1177-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respiratory failure or insufficiency. The ventilator is equipped with at least 2, NiMH battery modules (Part No. 6487180) which automatically supply 12V DC Power in case of an AC power failure, ensuring that ventilator settings and stored data remain intact in the event of an AC power failure. The battery modules give the user a possibility to use the SERVO-i during intra-hospital transportation.
Reason for recall
When using the SERVO-i on battery power, in a very small number of cases, some battery modules distributed after January 31, 2010 have a shorter battery run time than expected.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1177-2013 |
| Date reported | May 8, 2013 |
| Date initiated | March 7, 2013 |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc |
| Firm location | Wayne, NJ |
| Affected scope | 90,000 units (batteries) |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: ALGERIA, ANDORRA, ANTILLES (Netherlands), ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBADJAN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL, BRUNEI, BULGARIA, CANADA, CHILE… |
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-1177-2013) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026