ProxiDiagnost N90 — Class II medical device recall Z-2256-2020
Terminated recall by Philips North America, LLC, reported 2020-06-10, distributed nationwide. The thermo switches in the three-phase transformer, which normally aid in powering down the System Power Distr
| Recall number | Z-2256-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, LLC, Andover, MA, United States |
| Recall initiated | 2020-04-23 |
| Classified | 2020-06-03 |
| Reported by FDA | 2020-06-10 |
| Terminated | 2023-03-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL, DE |
| Quantity | 91 |
| Reason classes | device malfunction |
| Serial numbers | 10000000, 10000001, 10000004, 10000005, 10000006, 10000008, 10000009, 10000010, 10000011, 10000012, 10000013, 10000014, 10000015, 10000016, 10000017, 10000018, 10000019, 10000020, 10000021, 10000022, 10000023, 10000024, 10000025, 10000026, 10000028 and 62 more |
Product
ProxiDiagnost N90, UDI 706100
Reason for recall
The thermo switches in the three-phase transformer, which normally aid in powering down the System Power Distribution Unit, may be incorrectly installed and not working. If the transformer overheats due to a first failure and the thermo switch is not activated, the device may begin to generate smoke.
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-2256-2020. 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.