F2-01 Frame — Class II medical device recall Z-2656-2023
Ongoing recall by GE Medical Systems China Co., Ltd., reported 2023-10-11, distributed nationwide. There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARE
| Recall number | Z-2656-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems China Co., Ltd., Wuxi, N/A, China |
| Recall initiated | 2023-09-08 |
| Classified | 2023-09-29 |
| Reported by FDA | 2023-10-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BH, CH, CY, CZ, DE, ES, FI, FR, GB, IE, IT, KW, NL, NZ, OM, PL, QA, SA, SI, SK, TR |
| Quantity | 1,638 units |
| Serial numbers | SUT22280009HA, SUT22280011HA, SUT22280018HA, SUT22280025HA, SUT22280041HA, SUT22280042HA, SUT22290006HA, SUT22290007HA, SUT22290015HA, SUT22290023HA, SUT22290025HA, SUT22290026HA, SUT22290042HA, SUT22290045HA, SUT22290062HA, SUT22290064HA, SUT22290079HA, SUT22290080HA, SUT22290081HA, SUT22290082HA, SUT22300003HA, SUT22300004HA, SUT22300006HA, SUT22300007HA, SUT22300008HA and 475 more |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2656-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.