F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
FDA device recall Z-2656-2023 · posted 2023-09-29 · Open, Classified
Recall details
- Recalling firm
- GE Medical Systems China Co., Ltd.
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- MHX
- Quantity affected
- 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 Z
- Date initiated
- 2023-09-08
- Date posted
- 2023-09-29
- Location
- Wuxi, China
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) (K223531) | GE Healthcare Finland Oy | 2023-04-06 |