SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product
FDA device recall Z-0807-2014 · posted 2014-01-22 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable connector on the DASH, PDM, and/or Tram Module. May result in reduced ECG, Respiration and arrhythmia detection performance.
- Action taken
- GE Healthcare sent an Urgent Medical Device Correction letter dated December 5, 2013, to all affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Customers with questions were instructed to contact Technical Support at 1-800-558-7044. For questions regarding this recall call 262-513-4122.
- Root cause
- Pending
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 2516 (2,321 US, 195 OUS)
- Distribution
- Worldwide Distribution: US (nationwide) including DC and PR except SD, VT and WY; and Internationally to: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CHINA, COLOMBIA, COSTA RICA, CROATIA,
- Date initiated
- 2013-12-05
- Date posted
- 2014-01-22
- Date terminated
- 2016-07-25
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (K071073) | Ge Medical Systems Information Technologies | 2007-05-11 |