Philips CT Scanner UPS Accessory Recall for Battery Acid Leakage
Philips Medical Systems is recalling 847 UPS accessory devices for CT scanners 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 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 involves a risk-of-harm product (battery acid leakage, overheating, fumes) where injury has not yet been reported, which aligns with the 'High' severity criteria for medical devices.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 847 Uninterruptible Power Supply (UPS) accessory devices used with Brilliance CT 16 Slice Air Computed Tomography X-ray systems and Diagnostic Imaging systems. The recall was initiated after the firm was notified that the failure of these UPS devices may result in battery acid leakage, overheating, and/or the emission of fumes.
The affected devices are distributed worldwide, including the United States (nationwide, DC, and Puerto Rico) and numerous international locations. The specific model number is 728246, and the recall covers a specific list of serial numbers ranging from 3007 to 260086.
Consumers and healthcare facilities should check their equipment against the provided serial number list. If a device is affected, the firm should be contacted to arrange for the necessary corrective action to address the potential safety hazards.
The recalled product
- Product
- Brilliance CT 16 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 847
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 #: 728246
- Serial #s: 3007
- 3011
- 3014
- 3047
- 3050
- 3095
- 3117
- 3123
- 3162
- 3164
- 3170
- 3197
- 3247
- 3331
- 3407
- 3433
- 3458
- 3497
- 3578
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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