FDA Device recall Z-2116-2013
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient…
- FDA Device
- Class II
- terminated
- Published 2013-09-04
On 2013-09-04 the FDA classified a Class II recall of SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient… 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-2116-2013 |
| 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
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes.
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 # SA310290653GA SA310290655GA SA310290657GA SA310290659GA SA310290661GA SA310290748GA SA310290…Mfg Lot or Serial # SA310290653GA SA310290655GA SA310290657GA SA310290659GA SA310290661GA SA310290748GA SA310290749GA SA310290750GA SA310290754GA SA310290755GA SA310290756GA SA310290757GA SA310290758GA SA310290759GA SA310361647GA SA310361877GA SA310372108GA SA310393017GA SA310393052GA SA310382648GA SA310382626GA SA310382631GA SA310382729GA SA310382761GA SA310393037GA SA310393054GA SA310393071GA SA310393073GA SA310351531GA SA310361792GA SA310361798GA SA310361801GA SA310361803GA SA310361804GA SA310361805GA SA310361807GA SA310361808GA SA310361815GA SA310361820GA SA310361838GA SA310361840GA SA310361841GA SA310393150GA SA310393155GA SA310393162GA SA310393165GA SA310393166GA SA310393167GA SA310393170GA SA310393171GA SA310393173GA SA310393175GA SA310321055GA SA310321062GA SA310361949GA SA310382418GA SA310382450GA SA310382499GA SA310382513GA SA310382608GA SA310382647GA SA310382649GA SA310382663GA SA310393156GA SA310393158GA SA31 |
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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-2116-2013%22
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