Philips BrightView XCT Gamma Camera Recalled for Software Defect
Philips Medical Systems is recalling 424 BrightView XCT gamma cameras due to a software defect that may cause the detector to contact patients during specific scans.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of physical contact between the detector and the patient, which constitutes a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 424 units of the BrightView XCT Model 882482 gamma camera. The device is used for Single Photon Emission Computed Tomography (SPECT) imaging. The recall covers units distributed worldwide, including the United States and numerous international markets.
The recall was initiated because of a software defect in the workflow setup script. This defect may cause the detector to come into contact with the patient during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan. The issue was identified by the firm during its review of the device's software.
Healthcare facilities and consumers should stop using the affected devices and contact Philips Medical Systems for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 424
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 (20)
- 6000016
- 6000111
- 6000114
- 6000122
- 6000002
- 6000003
- 6000004
- 6000005
- 6000006
- 6000010
- 6000011
- 6000012
- 6000013
- 6000015
- 6000017
- 6000018
- 6000019
- 6000020
- 6000022
- 6000023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Philips Medical Systems (Cleveland) Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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