GE Healthcare Carescape Patient Data Module — Class II medical device recall Z-0060-2015
Terminated recall by GE Healthcare, LLC, reported 2014-10-15, distributed nationwide. GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a discon
| Recall number | Z-0060-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2014-09-19 |
| Classified | 2014-10-09 |
| Reported by FDA | 2014-10-15 |
| Terminated | 2016-09-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, CA, CH, CN, CO, CR, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HU, ID, IE, IL, IN, IS, IT, JM, JO, JP, KR, KW, LB, LT, MA, MX, MY, NO, NP, NZ, OM, PA, PE, PH, PL, PT, PY, QA, RU, SA, SE, SG, SK, TH, TN, TR, TT, TW, ZA |
| Serial numbers | SA307020379GR, SA307020383GR, SA307020386GR, SA307020391GR, SA307020393GA, SA307020396GA, SA307020397GA, SA307020399GR, SA307020400GA, SA307030405GR, SA307030411GR, SA307030412GR, SA307030413GR, SA307030417GA, SA307030419GA, SA307030420GA, SA307030423GA, SA307050429GA, SA307070436GR, SA307070438GR, SA307070441GR, SA307070442GR, SA307070446GA, SA307070447GR, SA307070448GA and 475 more |
Product
GE Healthcare Carescape Patient Data Module
Reason for recall
GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monitors. If the PDM is quickly disconnected and reconnected (a less than 10 second cycle) from a Carescape Bx50 monitor following a Patient Discharge or during active monitoring, the ECG waveform an
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-0060-2015. 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.