Philips CardioMD III UPS Accessory Devices Recalled for Battery Acid Leakage
Philips Medical Systems is recalling 81 CardioMD III UPS accessory devices for 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 product (battery acid leakage, overheating, fumes) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 81 units of CardioMD III 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 because the UPS accessory devices may fail, resulting in battery acid leakage, overheating, and/or the emission of fumes. The affected units were distributed worldwide, including the United States, DC, Puerto Rico, and numerous international locations.
Healthcare facilities and users of these specific systems should identify the affected units by checking the model number 882450 and the specific serial numbers listed in the official recall notice. Users should contact Philips Medical Systems for instructions on how to address the defect.
The recalled product
- Product
- CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 81
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 #: 882450
- Serial #s: 1106080
- 1122002
- 2112702
- 3101001
- 4042003
- 4112402
- 5032201
- 5032902
- 5042501
- 5060701
- 6030802
- 7092001
- 9042902
- 9053001
- 9061602
- 9070702
- 9081002
- 9083101
- 9083102
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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