GE F2-01 Frame Patient Monitor Communication Interruption Risk
GE F2-01 Frame physiological patient monitors may experience data communication interruptions with CARESCAPE ONE and CARESCAPE Canvas 1000 monitors if not powered down within 120 days.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving potential data communication interruption in patient monitoring equipment. No illnesses or injuries have been reported, but the hazard affects clinical operations by risking disruption of patient monitor data flow.
Plain-English summary
The GE F2-01 Frame is a physiological patient monitor designed to detect arrhythmias and provide alarms. The device connects to CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors via inserted E-modules.
A potential issue has been identified: if the F2-01 Frame has not been powered down within the last 120 days, data communication between the E-modules and the connected patient monitors may be interrupted. This interruption could disrupt the transfer of patient monitoring data between devices.
Approximately 1638 units have been distributed worldwide. Affected units can be identified by specific serial numbers beginning with "SUT" and the UDI/DI 010019527852408921.
Healthcare facilities should ensure F2-01 Frame devices are powered down at least once every 120 days to prevent potential communication interruptions. For additional guidance or concerns, contact GE Medical Systems China Co., Ltd.
The recalled product
- Product
- F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
- Manufacturer
- GE Medical Systems China Co., Ltd.
- Affected units
- 1,638
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 010019527852408921
- Serial Numbers: SUT23230108HA
- SUT23230111HA
- SUT23240034HA
- SUT23240035HA
- SUT23230106HA
- SUT23230107HA
- SUT23230109HA
- SUT23230110HA
- SUT23230112HA
- SUT23230113HA
- SUT23230114HA
- SUT23240001HA
- SUT23240002HA
- SUT23240003HA
- SUT23240004HA
- SUT23240005HA
- SUT23240006HA
- SUT23240007HA
- SUT23240008HA
Distribution
Distributed nationwide across the United States.
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