Philips BrightView XCT Gamma Camera Recall for Flat Panel Display Defect
Philips Medical Systems is recalling 407 BrightView XCT and BrightView X- gamma cameras because the Flat Panel Display may fail to remain securely locked in the deployed position.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a mechanical defect (display not locking) without reporting any specific injuries, illnesses, or deaths. This aligns with the rubric for moderate severity, representing a risk of harm where injury has not yet been reported or a voluntary precautionary measure.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 407 units of the BrightView XCT (product code 882482) and the BrightView X- upgraded with the XCT Flat Panel Detector (product code 882454). These are gamma cameras used for Single Photon Emission Computed Tomography (SPECT) medical imaging.
The recall is due to a defect where the Flat Panel Display (FPD) failed to remain securely locked in the deployed position. This issue could potentially compromise the stability of the imaging equipment during use.
The affected devices were distributed worldwide, including in the United States and numerous international countries. Healthcare facilities and government facilities in various US states and countries are affected. Users should contact Philips Medical Systems for instructions on how to address the defect.
The recalled product
- Product
- BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454. Gamma camera for Single Photon Emission Computed Tomography (SPECT) Medical Device for imaging.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 407
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)
- 6000004
- 6000005
- 6000006
- 6000010
- 6000011
- 6000012
- 6000013
- 6000015
- 6000016
- 6000017
- 6000018
- 6000019
- 600020
- 6000021
- 6000022
- 6000023
- 6000024
- 6000025
- 6000026
- 6000027
Distribution
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