GE Healthcare ApexPro Telemetry System for mobile patient physiological monitoring.
FDA device recall Z-1227-2009 · posted 2009-06-01 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- Intermittent or continuous loss of patient monitoring.
- Action taken
- Consignees were sent on 2/20/09 a GE Healthcare "Urgent Medical Device Correction" letter dated 2/12/09. The letter was addressed to Risk Manger/Chief of Nursing/Director of Biomedical Engineering. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 291
- Distribution
- Nationwide distribution and Canada.
- Date initiated
- 2009-02-24
- Date posted
- 2009-06-01
- Date terminated
- 2012-05-29
- Location
- Wauwatosa, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: APEXPRO TELEMETRY SYSTEM (K032369) | Ge Medical Systems Information Technologies | 2003-08-15 |