Emission Computed Tomography System Image Process System — Class II medical device recall Z-0852-2021
Terminated recall by Philips North America, LLC, reported 2021-01-20, distributed nationwide. A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.
| Recall number | Z-0852-2021 |
|---|---|
| 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 | 2020-11-19 |
| Classified | 2021-01-13 |
| Reported by FDA | 2021-01-20 |
| Terminated | 2023-04-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BH, BR, CA, CH, CN, CY, CZ, DE, DK, DZ, EG, ES, FI, FR, GB, GR, GT, ID, IE, IL, IN, IR, IT, JO, JP, KR, KW, LT, LV, MX, MY, NL, NO, NZ, PK, PL, PT, SA, SE, SG, TH, TR, TW, VE |
| Quantity | 2,714 |
| Reason classes | software |
| Model numbers | 882310, 882311, 882313 |
Product
Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
Reason for recall
A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.
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-0852-2021. 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.