SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE — Class II medical device recall Z-0648-2014
Terminated recall by GE Healthcare, LLC, reported 2014-01-15, distributed nationwide. GE Healthcare has recently become aware of a potential safety issue which affects all Patient Date Modules pro
| Recall number | Z-0648-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-12-16 |
| Classified | 2014-01-09 |
| Reported by FDA | 2014-01-15 |
| Terminated | 2016-04-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, GT, ID, IE, IL, IN, IT, JM, JO, JP, KR, KW, LB, LT, MA, MY, NL, NO, NZ, PL, QA, SA, SE, SG, TH, TN, TR, TT, TW, ZA |
| Serial numbers | SA307020379GA, SA307020383GA, SA307020384GA, SA307020386GA, SA307020391GA, SA307020393GA, SA307020396GA, SA307020397GA, SA307020398GA, SA307020399GA, SA307020400GA, SA307030405GA, SA307030407GA, SA307030409GA, SA307030411GA, SA307030412GA, SA307030413GA, SA307030414GA, SA307030417GA, SA307030419GA, SA307030420GA, SA307030423GA, SA307030424GA, SA307050429GA, SA307060432GA and 475 more |
Product
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0648-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.