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.
FDA Recall Z-0202-2018 · Posted None
Recalling FirmGE Medical Systems Information Technologies, Inc.
Recall StatusTerminated
Product CodeMHX
Date Initiated2017-07-13
Date Terminated2021-04-01
Product Quantity1,196 (1,176 US; 20 OUS)
Reason for Recall
Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.
Firm Action
GE Healthcare sent an Urgent Medical Device Correction letter dated July 12, 2017, to all affected consignees via certified mail. Consignees were advised to enable "Resp Rate (Impedance)" alarms and set the low limits to the factory defaults (NICU: 20/minute; Adult ICU: 5/minute). Consignees were also advised to enable audible alarms under Alarm Priorities for RR (Impedance) high/low. GE will provide a correction free of charge once it is available. GE will contact consignees to arrange device corrections. Consignees were instructed to call 1-800-558-7044 or a local representative with any questions pertaining to this recall.
Root Cause
Software Design Change
Distribution Pattern
Worldwide Distribution - US including NY, WI; Foreign: Australia, France, Germany.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.