GE Healthcare, LLC GE Healthcare Carescape Patient Data Module Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE Healthcare Carescape Patient Data Module
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Mfg Lot or Serial # SA307020379GR SA307020383GR SA307020386GR SA307020391GR SA307020393GA SA307020396GA SA307020397GA SA307020399GR SA307020400GA SA307030405GR SA307030411GR SA307030412GR SA307030413GR SA307030417GA SA307030419GA SA307030420GA SA307030423GA SA307050429GA SA307070436GR SA307070438GR SA307070441GR SA307070442GR SA307070446GA SA307070447GR SA307070448GA SA307070449GR SA307070450GR SA307070453GR SA307070454GR SA307070455GR SA307080459GA SA307080462GR SA307080463GR SA307080466GA SA307080467GA SA307080469GA SA307080472GA SA307080473GR SA307080477GR SA307080478GR SA307080484GA SA307080488GA SA307080489GA SA307080491GA SA307080493GR SA307080497GA SA307080498GR SA307080499GA SA307080502GR SA307080504GR SA307080508GR SA307080509GA SA307080510GR SA307080513GA SA307080520GR SA307080521GA SA307080522GR SA307080524GA SA307080525GR SA307080526GR SA307080533GR SA307105145GA SA307110544GA SA307110548GR SA307110556GA SA307110559GR SA307110560GR SA307110572GR SA307110575GR SA307110579GR 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GE Healthcare, LLC is recalling GE Healthcare Carescape Patient Data Module due to GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient D. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026