Philips iCT SP UPS Accessory Devices Recalled for Battery Acid Leakage Risk
Philips Medical Systems is recalling 110 iCT SP UPS accessory devices used with CT and diagnostic imaging systems 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 (battery acid leakage, overheating, fumes) from a medical device where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 110 units of iCT SP Uninterruptible Power Supply (UPS) accessory devices. These devices are used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. The recall was initiated after the firm was notified that the UPS accessory devices may fail, resulting in battery acid leakage, overheating, and/or emission of fumes.
The affected devices are identified by Model # 728311 and specific serial numbers ranging from 200021 to 200138, with certain gaps in the sequence. The products were distributed worldwide, including the United States (nationwide, DC, and Puerto Rico) and numerous international locations.
Consumers and healthcare facilities should check their inventory for these specific model and serial numbers. If the devices are found, they should be removed from service and the recalling firm contacted for further instructions.
The recalled product
- Product
- iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 110
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 #: 728311
- Serial #s: 200021
- 200022
- 200023
- 200024
- 200025
- 200026
- 200027
- 200029
- 200030
- 200031
- 200032
- 200033
- 200034
- 200035
- 200036
- 200037
- 200038
- 200039
- 200040
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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