F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
FDA Recall Z-2656-2023 · Posted 2023-09-29
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Recalling FirmGE Medical Systems China Co., Ltd.
Recall StatusOpen, Classified
Product CodeMHX
Date Initiated2023-09-08
Product Quantity1638 units
Reason for Recall
There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors if the F2-01 Frame has not been powered down within the last 120 days.
Firm Action
The consignee recall notification was sent out via FedEx on 09/08/2023. The letter instructs the consignee that they can continue to use the F2-01 Frame by completing the power down instructions located within the letter at least every 90 days, until GE HealthCare has corrected the affected device. The consignee is also requested to ensure all potential users in your facility are made aware of this safety notification and the recommended actions; retain the document for their records; and to complete and return the attached acknowledgement form to [email protected].
Root Cause
Software design
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Cyprus, Czech Republic, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, New Zealand, Oman, Poland, Qatar, Saudi Arabia, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
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.
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