Philips Recalls 84 BrightView SPECT Gamma Cameras Due to Brake Hub Defect
Philips is recalling 84 BrightView SPECT gamma cameras because a brake hub assembly error can cause the detector to backdrive.
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. The defect causes the detector to backdrive, which presents a risk of harm to patients or operators, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 84 units of the BrightView SPECT model number 882480. These are gamma cameras designed for single or dual detector nuclear imaging, including planar static, dynamic, gated, and total body studies, as well as SPECT studies.
The recall was initiated because the brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service. This defect causes the detector to backdrive.
The affected systems were distributed worldwide, including in the United States, Canada, Mexico, and numerous other international locations. The recall includes 11 government accounts in the US, 13 accounts in Canada, and 1 account in Mexico. Users of these devices should contact Philips Medical Systems for instructions on how to resolve the issue.
The recalled product
- Product
- BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, an
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 84
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)
- 4000008
- 4000287
- 4000497
- 4000364
- 4000346
- 4000557
- 4000423
- 4000088
- 4000029
- 4000631
- 4000339
- 4000072
- 4000643
- 4000640
- 4000420
- 4000543
- 4000010
- 4000282
- 4000216
- 4000415
Distribution
Part of a larger recall action
This product is one of 4 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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