Philips FORTE UPS Accessory Devices Recalled for Battery Acid Leakage Risk
Philips Medical Systems is recalling 10 FORTE Uninterruptible Power Supply (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 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 10 units of FORTE Uninterruptible Power Supply (UPS) accessory devices. These devices are used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. The recall is being conducted because the failure of these UPS accessory devices may result in battery acid leakage, overheating, and/or the emission of fumes.
The affected units are identified by Model # 882020 and specific serial numbers: 3102, 9908018, 9908021, F01100153, F02020009, F0208354, F02100382, FA05010041, M0005049, and W0002043. The distribution pattern for these devices is worldwide, including the United States (nationwide, including DC & Puerto Rico) and numerous international locations.
Healthcare facilities and users of these specific diagnostic imaging systems should verify if they possess the affected serial numbers. If a unit is identified, the firm should contact Philips Medical Systems (Cleveland) Inc for instructions on the recall and remediation of the device.
The recalled product
- Product
- FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Category
- Medical Device — Imaging Systems
- Affected units
- 10
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 (10)
- Model #: 882020
- Serial #s: 3102
- 9908018
- 9908021
- F01100153
- F02020009
- F0208354
- F02100382
- FA05010041
- M0005049 & W0002043.
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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