Philips MX 16 Slice Phase II CT Systems Recalled for UPS Battery Hazards
Philips is recalling 11 MX 16 Slice Phase II CT systems because their UPS accessory devices may leak battery acid, overheat, or emit fumes.
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.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 11 units of the MX 16 Slice Phase II Computed Tomography X-ray systems and Diagnostic Imaging systems. The recall involves specific Uninterruptible Power Supply (UPS) accessory devices used in conjunction with these 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 (nationwide, DC, and Puerto Rico) and numerous international locations.
Healthcare facilities should contact Philips Medical Systems (Cleveland) Inc for instructions on how to address the affected equipment. The specific serial numbers for the affected units are EP16ER100003, EP16ER100004, EP16ER100005, EP16ER100007, EP16ER100008, EP16ER110003, EP16ER110005, EP16ER110006, EP16ER110007, EP16ER110008, and EP16ER110009.
The recalled product
- Product
- MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 11
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 (11)
- Model #: 728132
- Serial #s: EP16ER100003
- EP16ER100004
- EP16ER100005
- EP16ER100007
- EP16ER100008
- EP16ER110003
- EP16ER110005
- EP16ER110006
- EP16ER110007
- EP16ER110008 & EP16ER110009.
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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