Philips Emission Computed Tomography System Software Defect Recall
Philips is recalling 2,714 Emission Computed Tomography Systems due to a software defect that may cause image misdiagnosis and incorrect patient treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a software defect with the potential for incorrect patient treatment, which aligns with the rubric criteria for Severe severity.
Plain-English summary
Philips North America, LLC is recalling 2,714 Emission Computed Tomography System Image Process Systems. The affected devices are intended for general Nuclear Medicine imaging procedures to detect radioisotope tracer uptake in the patient body. The recall involves Model numbers 882310, 882311, and 882313, all lots.
The recall is due to a software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient. The agency has classified this recall as Class II.
The affected products were distributed worldwide, including the United States, Canada, Mexico, and numerous other countries. Healthcare facilities and users of these systems should contact Philips North America, LLC for further instructions on how to address the software defect.
The recalled product
- 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.
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — Imaging Systems
- Affected units
- 2,714
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model# 882310
- 882311
- 882313 All Lots
Distribution
Distributed nationwide across the United States.
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