FDA Device recall Z-0524-2013
GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor
- FDA Device
- Class II
- terminated
- Published 2012-12-26
On 2012-12-26 the FDA classified a Class II recall of GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor by Ge Healthcare, citing GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0524-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-02-17 |
| Published | 2012-12-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | 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 |
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
GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care.
Identifiers
| code_info | Parent SN SA310310978GA SA310454946GA SA310475517GA SA310475525GA SA310475536GA SA310475537GA SA310475540GA SA3…Parent SN SA310310978GA SA310454946GA SA310475517GA SA310475525GA SA310475536GA SA310475537GA SA310475540GA SA310475566GA SA310475575GA SA310475581GA SA310475582GA SA310475585GA SA310475591GA SA310475598GA SA310475600GA SA310475608GA SA310475609GA SA310475610GA SA310475611GA SA310028114GR SA310028140GR SA310028149GR SA310149355GR SA310259884GA SA310259951GR SA310260040GA SA310260303GR SA310260308GR SA310260320GA SA310260359GR SA310260383GA SA310260402GA SA310260553GA SA310290668GA SA310310883GA SA310310926GA SA310310993GA SA310321001GA SA310341381GA SA310351501GA SA310361698GA SA310361707GA SA310361785GA SA310361945GA SA310372076GA SA310372167GR SA310372294GA SA310382325GR SA310382326GR SA310382347GR SA310382364GA SA310382635GA SA310382657GA SA310382754GA SA310382814GA SA310382838GA SA310382839GA SA310382849GA SA310392898GA SA310392937GR SA310393202GA SA310393246GA SA310393263GR SA310403312GA SA310403374GA SA310413458GA |
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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-0524-2013%22
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