FDA Devices recall · Reported October 15, 2014
GE Healthcare Carescape Patient Data Module
GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with th…
Ge Healthcare, LLC recalled GE Healthcare Carescape Patient Data Module - a moderate-severity action.
GE Healthcare Carescape Patient Data Module was recalled by Ge Healthcare, LLC in October 15, 2014. Reason: GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disc…. Check the official notice for the remedy. Verify recall #Z-0060-2015 with the FDA Devices before acting.
The recall
Ge Healthcare, LLC issued this moderate-severity FDA Devices recall-GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disc….
- Moderate
- severity level
- Class II
- classification
- October 15, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0060-2015 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
GE Healthcare Carescape Patient Data Module
Reason for recall
GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monitors. If the PDM is quickly disconnected and reconnected (a less than 10 second cycle) from a Carescape Bx50 monitor following a Patient Discharge or during active monitoring, the ECG waveform an
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0060-2015 |
| Date reported | October 15, 2014 |
| Date initiated | September 19, 2014 |
| Recalling firm | Ge Healthcare, LLC |
| Firm location | Waukesha, WI |
| Affected scope | 68,452 (39,505 units US, 24,711 units OUS, 4,236 units unidentified/unknown) |
| Distribution | Worldwide Distribution: US (nationwide) including DC, PR, Guantanamo except DE, HI, ND, SD & WY; and countries of: SOUTH AFRICA, KOREA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TUNISIA, TRINIDAD TOBAGO, THAILAND, TANZANIA, TAIWAN, SWI… |
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-0060-2015) 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