Class II — GE Healthcare, LLC
| Recalling firm | GE HealthCare Technologies Inc. |
|---|---|
| Registered facility | View this company's 50 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care. |
| 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. |
| Quantity | 10,250 |
| Distribution | Worldwide distribution, including the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, LA, KS, KY, LA, ME,MD, MA, MI, MN, MS,MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK OR, PA, SC, TN,TX, UT,VA, WA, WT, WY and the countries of the UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVAK IA, SINGAPORE, SAUDI ARABIA, QATAR, POLAND, PERU, PANAMA… |
| Initiated | 2012-02-17 |
| Classified | 2012-12-14 |
| Terminated | 2013-12-03 |
| Recall number | Z-0524-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GE Healthcare, LLC (Z-0524-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63655/
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