Severity
Moderate
ModerateClass IITerminated
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-0060-2015) was formally reported on October 15, 2014, with the manufacturer initiating the action on September 19, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Ge Healthcare, LLC is listed as the recalling firm, operating out of Waukesha, WI. Federal records list the affected scope as 68,452 (39,505 units US, 24,711 units OUS, 4,236 units unidentified/unknown).
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: 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, T…. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
68,452 (39,505 units US, 24,711 units OUS, 4,236 units unidentified/unknown)
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
GE Healthcare Carescape Patient Data Module. Recalled by Ge Healthcare, LLC. Units affected: 68,452 (39,505 units US, 24,711 units OUS, 4,236 units unidentified/unknown).
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 15, 2014. Severity: Moderate. Recall number: Z-0060-2015.
Where was the recalled product distributed? ▼
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, SWITZERLAND, SWEDEN, SPAIN, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIA, QATAR, BRASIL, PORTUGAL, POLAND, PHILIPPINES, PERU, PANAMA, PARAGUAY, OMAN, NEW ZEALAND, NORWAY, NETHERLAND, NEPAL, MYANMAR, MEXICO, MOROCCO, MALDOVA, MAURITIUS, MALAYSIA, LITHUANIA, LEBANON, BAHRAIN, KUWAIT, REPUBLIC OF KOREA, JAPAN, JORDAN, JAMAICA, ITALY, ISRAEL, IRELAND, INDONESIA, INDIA, ICELAND, HUNGARY, HONG KONG, GUATEMALA, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT,ECUADOR, DENMARK, CECH REPUBLIC, COSTA RICA, COLOMBIA,, CHINA, CANADA, BULGARIA, BELGIUM BANGLADESH, AUSTRIA, AUSTRALIA, and ARGENTINA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0060-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 15, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.