FDA Device recall Z-0648-2014
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)
- FDA Device
- Class II
- terminated
- Published 2014-01-15
On 2014-01-15 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) by Ge Healthcare, citing GE Healthcare has recently become aware of a potential safety issue which affects all Patient Date Modules produced from April 2007 through June 2010, encompassing Fiscal Week 13,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0648-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-16 |
| Published | 2014-01-15 |
| 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)
Reason
GE Healthcare has recently become aware of a potential safety issue which affects all Patient Date Modules produced from April 2007 through June 2010, encompassing Fiscal Week 13, 2007 through 26, 2010 due to fluid ingress into the top cover assembly which can result in heat buildup.
Identifiers
| code_info | Mfg Lot or Serial # SA307140598GA SA307140599GA SA307140600GA SA307140601GA SA307140605GA SA307140606GA SA307140…Mfg Lot or Serial # SA307140598GA SA307140599GA SA307140600GA SA307140601GA SA307140605GA SA307140606GA SA307140607GA SA307140610GA SA307140611GA SA307140612GA SA307140614GA SA307140615GA SA307140618GA SA307140619GA SA307140622GA SA307140623GA SA307140627GA SA307140628GA SA307140631GA SA307140632GA SA307140636GA SA307140637GA SA307140639GA SA307140640GA SA307140641GA SA307140642GA SA307140644GA SA307150645GA SA307150646GA SA307150655GA SA307150656GA SA307020391GA SA307030405GA SA307030424GA SA307070446GA SA307070447GA SA307070448GA SA307080462GA SA307080463GA SA307080484GA SA307080508GA SA307080523GA SA307110548GA SA307110556GA SA307110571GA SA307190716GA SA307190737GA SA307190739GA SA307190750GA SA307190768GA SA307020379GA SA307020384GA SA307020386GA SA307030407GA SA307030409GA SA307030412GA SA307030414GA SA307060432GA SA307070436GA SA307070440GA SA307070441GA SA307070442GA SA307070450GA SA307070453GA SA307070454GA SA30 |
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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-0648-2014%22
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