FDA Device recall Z-0202-2018
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 i…
- FDA Device
- Class II
- terminated
- Published 2017-12-13
On 2017-12-13 the FDA classified a Class II recall of 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 i… by Ge Medical Systems Information Technologies, citing device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0202-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-13 |
| Published | 2017-12-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Medical Systems Information Technologies |
| Distribution | NY, WI |
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
Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.
Identifiers
| code_info | Model No. 2042084-001. Serial No. SA314096842GA, SA314212130GA, SA313430730GA, SA313430743GA, SA313430731GA, SA3134307…Model No. 2042084-001. Serial No. SA314096842GA, SA314212130GA, SA313430730GA, SA313430743GA, SA313430731GA, SA313430735GA, SA313430771GA, SA313430795GA, SA313430801GA, SA313430806GA, SA313430813GA, SA313441307GA, SA313441311GA, SA313441399GA, SA313441414GA, SA313441474GA, SA314086697GA, SA313272250GA, SA313378480GA, SA313419589GA, SA313430691GA, SA313430697GA, SA313430700GA, SA313430705GA, SA313430706GA, SA313430711GA, SA313430713GA, SA313430715GA, SA313430723GA, SA313430724GA, SA313430751GA, SA313430752GA, SA313430753GA, SA313430755GA, SA313430757GA, SA313430759GA, SA313430761GA, SA313430762GA, SA313430763GA, SA313430764GA, SA313430766GA, SA313430767GA, SA313430777GA, SA313430779GA, SA313430780GA, SA313430781GA, SA313430783GA, SA313430784GA, SA313430789GA, SA313430790GA, SA313430792GA, SA313430793GA, SA313430794GA, SA313430796GA, SA313430797GA, SA313430798GA, SA313430799GA, SA313430802GA, SA313430804GA, SA313430805GA, SA313430807GA, SA313430808GA, SA313430809GA, SA313430812GA,SA |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0202-2018%22
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