GE Healthcare — Class II medical device recall Z-0823-2013
Terminated recall by GE Healthcare, LLC, reported 2013-02-20, distributed in AL, AR, AZ, CA, CO, CT, FL, GA…. GE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650. There have been
| Recall number | Z-0823-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2011-09-30 |
| Classified | 2013-02-14 |
| Reported by FDA | 2013-02-20 |
| Terminated | 2014-01-27 |
| Distributed | AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI |
| Countries outside the US | AE, AT, AU, BE, BH, CA, CH, CL, CO, CZ, DE, DK, EG, ES, FI, FR, GB, HK, IE, IL, IN, IS, IT, JP, KW, LT, MY, NO, NZ, PE, PL, PT, RO, SA, SE, SG, SI, SK, TH, TR, ZA |
| Quantity | 2,813 |
| Serial numbers | SED08349999GP, SEW10233204HA, SEW10233206HA, SEW10233209HA, SEW10233210HA, SEW10243447HA, SEW10243466HA, SEW10243467HA, SEW10243468HA, SEW10243469HA, SEW10243470HA, SEW10243477HA, SEW10243478HA, SEW10243479HA, SEW10243484HA, SEW10243489HA, SEW10243490HA, SEW10243491HA, SEW10243492HA, SEW10243499HA, SEW10243500HA, SEW10243503HA, SEW10243504HA, SEW10243508HA, SEW10243514HA and 475 more |
Product
GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.
Reason for recall
GE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650. There have been no reported illnesses or injuries that have occurred with the use of the device.
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-0823-2013. 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.