Philips BrightView Gamma Cameras Recalled for Patient Contact Risk
Philips is recalling 1,143 BrightView gamma cameras because a positioning error can cause detectors to contact patients during imaging.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device defect that resulted in physical contact with patients, which constitutes a significant injury risk under the rubric for Severe recalls.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 1,143 units of BrightView XCT, BrightView X, and BrightView SPECT gamma cameras. These devices are used for nuclear imaging and are distributed worldwide, including in the United States and numerous international markets.
The recall is due to a reported defect where the second detector may not position correctly during specific non-circular acquisitions. This error can cause the detectors to come into contact with the patient when the acquisition begins. The firm reported three instances of this problem.
Healthcare facilities should stop using the affected units and contact Philips for instructions on corrective action. Patients who have undergone imaging with these devices should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 1,143
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)
- BrightView SPECT
- Product code: 882480
- Serial #'s: 400054
- 4000002
- 4000003
- 4000004
- 4000006
- 4000007
- 4000008
- 4000009
- 4000010
- 4000011
- 4000013
- 4000029
- 4000030
- 4000031
- 4000032
- 4000033
- 4000034
- 4000035
Distribution
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