CARESCAPE Patient Data Module — Class II medical device recall Z-0202-2018
Terminated recall by GE Medical Systems Information Technologies, Inc., reported 2017-12-13, distributed in NY, WI. Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apne
| Recall number | Z-0202-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems Information Technologies, Inc., Milwaukee, WI, United States |
| Recall initiated | 2017-07-13 |
| Classified | 2017-12-06 |
| Reported by FDA | 2017-12-13 |
| Terminated | 2021-04-01 |
| Distributed | NY, WI |
| Countries outside the US | AU, DE, FR |
| Serial numbers | SA307362382GA, SA307382531GA, SA307382574GA, SA307382601GA, SA307382612GA, SA307443225GA, SA307443239GA, SA307443250GA, SA307443253GA, SA307443365GA, SA307443370GA, SA307453391GA, SA307453411GA, SA307453414GA, SA307453418GA, SA307453551GA, SA307453558GA, SA307453598GA, SA307453604GA, SA307453606GA, SA307483768GA, SA307483774GA, SA307483786GA, SA307483811GA, SA307493932GA and 475 more |
| Model numbers | 2042084-001 |
Product
CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The 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. Physiological parameter data acquired by the PDM includes EGG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes.
Reason for recall
Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.
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-0202-2018. 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.