Philips recalls certain Emission Computed Tomography Image Process Systems due to a software defect that may cause image misdiagnosis and incorrect patient treatment. Affected models include 882310, 882311, and 882313.
A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.
Philips is recalling specific Emission Computed Tomography Image Process Systems that could cause image misdiagnosis and incorrect patient treatment due to a software defect. This affects medical imaging equipment used in nuclear medicine procedures.
A software defect in the system can lead to image misdiagnosis, which may result in incorrect patient treatment. This defect occurs during nuclear medicine imaging procedures where the system detects radioisotope tracer uptake in the body.
Healthcare facilities using Philips Emission Computed Tomography Image Process Systems with model numbers 882310, 882311, or 882313 are likely affected. Medical staff and patients using these systems for nuclear medicine imaging procedures are at risk.
Check if your Philips Emission Computed Tomography Image Process System has model numbers 882310, 882311, or 882313. All lots of these models are affected by the recall.
Identify the model number on your Philips Emission Computed Tomography Image Process System to confirm if it is affected (882310, 882311, or 882313).
The recall record states a software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient, but does not specify the exact nature of the defect.
The recall does not specify a remedy or immediate action, so there is no requirement to stop using the system immediately.
Check the model number on your Philips Emission Computed Tomography Image Process System; affected models are 882310, 882311, and 882313.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0852-2021 — Philips Philips Hello, I own a Philips that is covered by recall Z-0852-2021 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
