GE Healthcare — Class II medical device recall Z-2201-2013
Terminated recall by GE Healthcare, LLC, reported 2013-09-25, distributed nationwide. GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 when used with
| Recall number | Z-2201-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2011-07-20 |
| Classified | 2013-09-16 |
| Reported by FDA | 2013-09-25 |
| Terminated | 2013-10-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, CA, CH, CL, CN, CO, CR, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, ID, IE, IL, IN, IQ, IT, JO, JP, KR, KW, MX, MY, NL, NO, NP, PL, PT, PY, RS, SA, SE, SG, SK, TH, TN, TR, ZA |
| Reason classes | software |
| Serial numbers | 6585804, 6585808, 6585809, 6585810, 6585811, 6585812, 6614833, 6617967, 6617968, 6617969, 6619123, 6619124, 6619157, 6619158, 6619159, 6619160, 6626633, 6626634, 6637282, 6637287, 6654942, 6654944, 6660104, 6660108, 6660109 and 475 more |
Product
GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.
Reason for recall
GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 when used with the iCentral network. The iCentral must have the alarm management software license (L-NETM-00) and the alarm limit change option enabled to experience this issue. When changing the HR, SpO2 or Invasive pressure alarm limits from the iCentral over the network, the alarm priority on th
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-2201-2013. 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.