FDA Device recall Z-0823-2013
GE Healthcare, CARESCAPE Monitor B650
- FDA Device
- Class II
- terminated
- Published 2013-02-20
On 2013-02-20 the FDA classified a Class II recall of GE Healthcare, CARESCAPE Monitor B650 by Ge Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0823-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-09-30 |
| Published | 2013-02-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | 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 |
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
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.
Identifiers
| code_info | SERIAL NUMBER SEW1181782HA SEW11243524HA SEW11223123HA SEW11223122HA SEW11223121HA SEW11223108HA SEW11223107HA…SERIAL NUMBER SEW1181782HA SEW11243524HA SEW11223123HA SEW11223122HA SEW11223121HA SEW11223108HA SEW11223107HA SEW11223106HA SEW11223092HA SEW11223086HA SEW11223085HA SEW11223082HA SEW11223070HA SEW11223022HA SEW11223019HA SEW11223011HA SEW11222999HA SEW11222997HA SEW11202780HA SEW11202778HA SEW11202775HA SEW11202753HA SEW11202750HA SEW11202749HA SEW11202746HA SEW11202745HA SEW11202744HA SEW11202742HA SEW11202741HA SEW11202740HA SEW11202739HA SEW11202737HA SEW11202736HA SEW11202717HA SEW11202716HA SEW11202715HA SEW11202713HA SEW11202712HA SEW11202711HA SEW11202709HA SEW11202708HA SEW11202706HA SEW11202705HA SEW11202704HA SEW11202703HA SEW11202702HA SEW11202700HA SEW11202697HA SEW11202690HA SEW11202687HA SEW11202682HA SEW11202401HA SEW11202400HA SEW11202399HA SEW11202398HA SEW11202397HA SEW11202395HA SEW11202394HA SEW11202390HA SEW11202385HA SEW11202384HA SEW11202383HA SEW11202381HA SEW11202379HA SEW11202378HA SEW11202370 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0823-2013%22
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