F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)

Recall Insight

This FDA Devices action (record #Z-2656-2023) was formally reported on October 11, 2023, with the manufacturer initiating the action on September 8, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. GE Medical Systems China Co., Ltd. is listed as the recalling firm, operating out of Wuxi, N/A. Federal records indicate 1638 units units are affected.

The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: 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, Polan…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 3 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.