FDA Device recall Z-0852-2021
Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for dete…
- FDA Device
- Class II
- terminated
- Published 2021-01-20
On 2021-01-20 the FDA classified a Class II recall of Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for dete… by Philips North America, citing A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0852-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-19 |
| Published | 2021-01-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | US |
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
A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.
Identifiers
| code_info | Model# 882310,882311,882313 All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0852-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.