Philips Medical Systems Recalls Extended Brilliance Workstation UPS Accessories
Philips Medical Systems is recalling Extended Brilliance Workstation UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.
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 is classified as FDA Class II and involves significant injury risks, including battery acid leakage and overheating, which aligns with the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling Extended Brilliance Workstation Uninterruptible Power Supply (UPS) accessory devices used with Computed Tomography X-ray systems and Diagnostic Imaging systems. The recall is being conducted because the firm was notified that failure of these UPS accessory devices may result in battery acid leakage, overheating, and/or emission of fumes.
The affected product is identified by Model number 728260 and Serial number 13216. The recall covers 1 unit distributed worldwide, including the United States (nationwide, DC, and Puerto Rico) and numerous international locations. The agency has classified this recall as Class II.
Consumers and healthcare facilities should contact the recalling firm for instructions on how to address the potential safety hazards associated with the UPS accessory devices.
The recalled product
- Product
- Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 1
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 (2)
- Model #: 728260
- Serial #: 13216
Distribution
Part of a larger recall action
This product is one of 35 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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