GE Healthcare — Class II medical device recall Z-2085-2014
Terminated recall by GE Healthcare, LLC, reported 2014-07-30, distributed nationwide. Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Dat
| Recall number | Z-2085-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2014-06-13 |
| Classified | 2014-07-21 |
| Reported by FDA | 2014-07-30 |
| Terminated | 2016-09-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BM, CH, CL, CY, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, HR, HU, ID, IE, IL, IN, IQ, IS, IT, JM, JO, JP, LB, LT, LV, MA, MX, MY, NL, NO, NZ, PA, PH, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, TR, TW, ZA |
| Reason classes | software |
Product
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
Reason for recall
Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor and loss of the PDM parameters could occur.
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-2085-2014. 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.