GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is
FDA device recall Z-1291-03 · posted 2003-09-23 · Terminated
Recall details
- Recalling firm
- GE Medical Systems Information Technologies
- Reason for recall
- The 2120 Main Board on device lacks required external safety 'watchdog' circuit.
- Action taken
- The firm mailed or faxed a recall letter to consignees on May 14, 2003 followed by a phone call to each account within two weeks to arrange for a service technician visit to correct the monitors. The recall letter warned the hospitals of the problem and a work around.
- Root cause
- Other
- Status
- Terminated
- Product code
- HGM
- Quantity affected
- 170
- Distribution
- The monitors were distributed to 8 hospitals in SC, WI, CA, MN, TX, MD and NV, as well as two hospitals in France.
- Date initiated
- 2003-05-21
- Date posted
- 2003-09-23
- Date terminated
- 2003-10-27
- Location
- Tampa, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODEL 2120IS SERIES MATERNAL/FETAL MONITOR (K021135) | Ge Medical Systems Information Technologies | 2002-05-09 |