GE Healthcare Carescape Patient Data Module The Patient Data Module — Class II medical device recall Z-0747-2014
Terminated recall by GE Healthcare, LLC, reported 2014-01-22, distributed nationwide. GE Healthcare has recently become aware of a potential safety issue due to intermittent failure of the spring
| Recall number | Z-0747-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-11-27 |
| Classified | 2014-01-14 |
| Reported by FDA | 2014-01-22 |
| Terminated | 2016-09-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, GT, HU, ID, IE, IL, IN, IT, JM, JO, JP, KR, KW, LB, LT, MA, MX, MY, NL, NO, NP, NZ, OM, PA, PE, PK, PL, PT, PY, QA, RU, SA, SE, SG, SK, 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
GE Healthcare Carescape Patient Data Module 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 for recall
GE Healthcare has recently become aware of a potential safety issue due to intermittent failure of the spring loaded mounting latch of PDMs produced from April 2007 through December 2012.
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-0747-2014. 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.