FDA Devices recall · Reported December 13, 2017
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.
Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.
Ge Medical Systems Information Technologies, Inc. recalled CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650… - a moderate-severity action.
CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650… was recalled by Ge Medical Systems Information Technologies, Inc. in December 13, 2017. Reason: Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apn…. Check the official notice for the remedy. Verify recall #Z-0202-2018 with the FDA Devices before acting.
The recall
Ge Medical Systems Information Technologies, Inc. issued this moderate-severity FDA Devices recall-Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apn….
- Moderate
- severity level
- Class II
- classification
- December 13, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0202-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0202-2018 |
| Date reported | December 13, 2017 |
| Date initiated | July 13, 2017 |
| Recalling firm | Ge Medical Systems Information Technologies, Inc. |
| Firm location | Milwaukee, WI |
| Affected scope | 1,196 (1,176 US; 20 OUS) |
| Distribution | Worldwide Distribution - US including NY, WI; Foreign: Australia, France, Germany. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0202-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026