CLASS II Device recall · Reported 13 Dec 2017 · FDA Enforcement Report
Carescape Patient Data Module (PDM) v2.6 recalled by GE Medical Systems
GE Medical Systems Information Technologies is recalling Carescape Patient Data Module (PDM) v2.6, distributed in New York, Wisconsin. The recall was initiated on 13 Jul 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0202-2018
- FDA event ID
- 77818
- Recalling firm
- GE Medical Systems Information Technologies, Milwaukee, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jul 2017
- FDA classified
- 6 Dec 2017
- Reported
- 13 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 13 Jul 2017 | Recall initiated by company | |
| 6 Dec 2017 | Classified by FDA | +146 days |
| 13 Dec 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US including NY, WI; Foreign: Australia, France, Germany.
Questions about this recall
Why was it recalled?
Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.
Which lots are affected?
Model No. 2042084-001. 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Where was it sold?
Worldwide Distribution - US including NY, WI; Foreign: Australia, France, Germany.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from GE Medical Systems Information Technologies
All 19Other Patient Monitors recalls
All 1,022| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Passport Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | T1 Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | cPM Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneVision Series Telemetry Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | Panorama and Telemetry Monitoring System recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |