GE Healthcare Carescape Patient Data Module with v2 — Class II medical device recall Z-0524-2013
Terminated recall by GE Healthcare, LLC, reported 2012-12-26, distributed in AK, AL, AR, AZ, CA, CO, CT, FL…. GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impa
| Recall number | Z-0524-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-02-17 |
| Classified | 2012-12-14 |
| Reported by FDA | 2012-12-26 |
| Terminated | 2013-12-03 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WY |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CO, CR, CZ, DE, DZ, EG, ES, FI, FR, GB, ID, IE, IN, IT, JP, KR, KW, LB, MX, MY, NO, NZ, PA, PE, PL, QA, SA, SE, SG, TH, TR, ZA |
| Quantity | 10,250 |
| Reason classes | software |
Product
GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and transport patient care episodes.
Reason for recall
GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care.
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-0524-2013. 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.