Philips BrightView X Gamma Camera Recalled for Software Defect
Philips Medical Systems is recalling 117 BrightView X gamma cameras due to a software defect that may cause the detector to contact patients during specific scans.
What this means for you
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 harm (detector contacting the patient) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 117 units of the BrightView X gamma camera, model #882478. This medical device is designed for single or dual detector nuclear imaging. The recall is due to a software defect in the workflow setup script.
The defect may cause the detector to come into contact with a 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.
The affected units were distributed worldwide, including in the United States and numerous other countries. No specific lot numbers or serial ranges are provided in the source text beyond the model number. Healthcare facilities should contact Philips Medical Systems for instructions on how to address the software defect.
The recalled product
- Product
- BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 117
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)
- 11000003
- 11000008
- 11000030
- 11000004
- 11000005
- 11000006
- 11000007
- 11000009
- 11000010
- 11000011
- 11000012
- 11000013
- 11000014
- 11000016
- 11000017
- 11000018
- 11000019
- 11000020
- 11000022
- 11000023
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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