FDA Device recall Z-2117-2013
GE Healthcare, TRAM MODULE, High-acuity patient monitoring
- FDA Device
- Class II
- terminated
- Published 2013-09-04
On 2013-09-04 the FDA classified a Class II recall of GE Healthcare, TRAM MODULE, High-acuity patient monitoring by Ge Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2117-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-03 |
| Published | 2013-09-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another.
Reason
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.
Identifiers
| code_info | Mfg Lot or Serial # RT412081449GA RT412081483GA RT412091489GA RT412091490GA RT412091492GA RT412091510GA RT412091…Mfg Lot or Serial # RT412081449GA RT412081483GA RT412091489GA RT412091490GA RT412091492GA RT412091510GA RT412091511GA RT412091517GA RT412091522GA SBB12281535GA RT412101534GA SBB12281525GA SBB12281528GA SBB12281561GA SBB12301640GA SBB12361656GA SBB12361658GA SBB12361659GA SBB12361660GA SBB12361661GA SBB12361662GA SBB12361663GA SBB12301635GA RT411220584GA RT412081484GA RT412091488GA RT412091501GA RT412101576GA RT412101599GA RT412101601GA RT412101604GA RT412101605GA RT412101606GA RT412101609GA RT412101611GA RT412101621GA RT412101624GA RT412101626GA RT412101628GA RT412101629GA RT412101632GA RT412101646GA RT412101655GA RT412101657GA RT412101661GA RT412101662GA RT412101663GA RTW11346657GA RTW11346667GA RTW11366669GA RTW11366672GA RTW11366673GA RTW11366674GA RTW11366691GA RTW11366695GA RTW11366697GA RTW11366700GA RTW11366701GA RTW11366702GA RTW11366704GA RTW11366712GA RTW11366715GAMKE RTW11366721GA RTW11366722GA RTW11366724GA R |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2117-2013%22
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