GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninte
FDA device recall Z-0808-2014 · 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
- 1,948 (1,834 US; 114 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 |
|---|---|---|
| TRAM MODULE (K053121) | GE Healthcare | 2006-04-05 |
| TRAM 2001 MODULE (K011000) | General Electric Medical Systems Information Techn | 2001-06-29 |
| TRAM PATIENT MONITOR (K900540) | Marquette Electronics, Inc. | 1990-07-17 |