GE ApexPro CH Telemetry System. The ApexPro Telemetry System is composed of 6 major components. -The patient worn data a
FDA device recall Z-0055-2007 · posted 2006-10-20 · Terminated
Recall details
- Recalling firm
- Ge Healthcare
- Reason for recall
- When a patient being monitored with ApexPro/Apex Pro CH Telemetry with ST monitoring disabled is in a pre-existing condition of continuous MESSAGE or ADVISORY level alarm preceding a SYSTEM WARNING level alarm, the SYSTEM WARNING audible alarm and flashing yellow border around the patient panel at the CIC (Clinical Information Center) does not occur.
- Action taken
- An Urgent Medical Device Correction letter dated August 04, 2006 was sent to customers with affected devices. The letter described the issue affecting devices containing software versions v3.8 and earlier, provides short term recommendations and a long term solution of updating the software.
- Root cause
- Other
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 5,203
- Distribution
- Worldwide-USA and Puerto Rico and countries of ,Australia, Belgium, Canada, China, Croatia, Czech Republic, Estonia, Finland, France, Germany, Great Britain, Greece, Guam, Honduras, Hong Kong, Hunary,
- Date initiated
- 2006-08-04
- Date posted
- 2006-10-20
- Date terminated
- 2012-07-03
- Location
- Wauwatosa, WI
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: APEXPRO TELEMETRY SYSTEM (K032369) | Ge Medical Systems Information Technologies | 2003-08-15 |