Philips Recalls BrightView SPECT Gamma Cameras Due to Mechanical Failure
Philips Medical Systems is recalling 505 BrightView SPECT gamma cameras worldwide after a report of unexpected detector motion caused by a mechanical assembly failure.
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 mechanical failure causing unexpected motion of a medical imaging detector, which poses a risk of harm to patients or operators, but no injuries or deaths are reported in the source text.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 505 units of the BrightView SPECT gamma camera for Emission Computed Tomography. The recall is being conducted due to a report from the field indicating that the detector experienced unexpected motion resulting from a failure of the mechanical assembly.
The affected devices are distributed worldwide, including in the United States and numerous international markets. The specific units are identified by Model # 882480 and a specific list of serial numbers provided in the official recall documentation.
Healthcare facilities and users should stop using the affected BrightView SPECT gamma cameras and contact Philips Medical Systems for instructions on how to proceed with the recall and any necessary repairs or replacements.
The recalled product
- Product
- BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 505
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)
- Model # 882480
- Serial #'s: 400054
- 400381
- 4000089
- 4000090
- 4000091
- 4000093
- 4000094
- 4000095
- 4000098
- 4000099
- 4000100
- 4000102
- 4000103
- 4000104
- 4000105
- 4000106
- 4000107
- 4000108
- 4000109
Distribution
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