Recall Z-2656-2023 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Medical Systems China Co., Ltd.
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
| Date | Sep 29, 2023 (initiated Sep 8, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| 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 Recall.36160@ge.com. |
| Quantity | 1638 units |
| Distribution | 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 Ar |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223531 | CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) GE Healthcare Finland Oy, Apr 6, 2023 |