Philips Recalls BrightView XCT Gamma Cameras Due to Latch Failure
Philips is recalling 371 BrightView XCT gamma cameras because the Flat Panel Detector may not remain securely latched in the stowed 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, and the hazard involves a mechanical latch failure without reported injuries or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 371 units of the BrightView XCT gamma camera. This medical device is used for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components.
The recall was initiated after Philips received field reports indicating that the Flat Panel Detector (FPD) does not always remain securely latched in the stowed position. The affected units are distributed worldwide, including in the United States and numerous international locations.
Healthcare facilities and users should identify affected units by checking the model and serial numbers listed in the official recall notice. Affected model numbers include 882454 and 882482, with specific serial numbers detailed in the FDA record. Users should contact Philips Medical Systems for instructions on how to address the defect.
The recalled product
- Product
- BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 371
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)
- 11000082
- and 11000111. Model Number: 882482 Serial Number(s): 6000002
- 6000003
- 6000004A
- 6000005
- 6000010
- 6000011
- 6000012
- 6000013
- 6000015
- 6000016
- 6000017
- 6000018
- 6000019
- 6000020
- 6000022
- 6000023
- 6000024
- 6000025
- 6000026
Distribution
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