MAQUET Getinge Group CARDIOHELP Base Unit REF 70104 — Class II medical device recall Z-0082-2014
Terminated recall by Maquet Medical Systems USA, reported 2013-11-06, distributed nationwide. It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device may display an
| Recall number | Z-0082-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Medical Systems USA, Wayne, NJ, United States |
| Recall initiated | 2013-09-12 |
| Classified | 2013-10-25 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2017-06-07 |
| Distributed | Nationwide (US) |
| Quantity | 63 |
| Serial numbers | 90410440, 90410452, 90410455, 90410456, 90410457, 90410459, 90410469, 90410474, 904104781, 90410480, 90410482, 90410484, 90410498, 90410499, 90410500, 90410501, 90410502, 90410503, 90410521, 90410522, 90410524, 90410526, 90410527, 90410531, 90410533 and 57 more |
| Model numbers | 70104.7999, 70104.8012 |
Product
MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system.
Reason for recall
It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device may display an error message with audible alarm, indicating "battery defective." The alarm will occur-upon start up or when the main power supply is unplugged from the main power source. The human machine interface touch screen of the CARDIOHELP-i device may gradually become black due to the human machine interface (HMI) back light shutting down.
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-0082-2014. 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.