GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninte
FDA device recall Z-2117-2013 · posted 2013-08-28 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/or Tram Module. ECG and Respiration signal noise caused by DASH, PDM, and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance.
- Action taken
- GE Healthcare "Urgent Medical Device Correction" letter dated April 3, 2013 to all affected customers. The letter was addressed to Healthcare Administrator / Risk manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Product, Safety Instructions, Affected Product Details, and Product Correction. For questions contact Technical Support at 1-800-558-7044.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 4807 (2167 US, 2207 OUS, & 434 unknown.
- Distribution
- Worldwide Distribution - USA Nationwide including DC and PR except ND and the countries of: ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOSNIA-HERZE
- Date initiated
- 2013-04-03
- Date posted
- 2013-08-28
- Date terminated
- 2016-07-25
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRAM MODULE (K053121) | GE Healthcare | 2006-04-05 |