Recall Z-2656-2023— GE Medical Systems China Co., Ltd.

Name: FDA recall Z-2656-2023
Creator: U.S. Food and Drug Administration
Published: 2023-09-08

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems China Co., Ltd., initiated 2023-09-08. It names one FDA 510(k) clearance: K223531. Product: F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms). Reason: 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..

Recalling firm: GE Medical Systems China Co., Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2023-09-08
Firm location: Wuxi, N/A, China

510(k) clearances named in this recall

1 on FDA's record

K223531 — CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)GE Healthcare Finland Oy·cleared 2023-04-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.