Data Foundry

Medical device recalls 2013

Maquet Getinge Group battery modules for use with Maquet SERVO-i… — Class I medical device recall Z-1177-2013

Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2013-05-08, distributed nationwide. When using the SERVO-i on battery power, in a very small number of cases, some battery modules distributed aft

Recall numberZ-1177-2013
Product typeMedical device
ClassificationClass I
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMaquet Cardiovascular Us Sales, Llc, Wayne, NJ, United States
Recall initiated2013-03-07
Classified2013-04-26
Reported by FDA2013-05-08
Terminated2016-08-11
DistributedNationwide (US)
Countries outside the USAE, AR, AT, AU, AW, BD, BE, BG, BO, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JM, JP, KE, KR, KW, LK, LT, LV, MA, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SV, TH, TN, TR, TT, TW, UA, UY, VE, VN, ZA
Quantity90,000 units
Model numbers6487180

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1177-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.