Philips Recalls GEMINI TF PET/CT 64 Slice UPS Accessory Devices
Philips Medical Systems is recalling 71 GEMINI TF PET/CT 64 Slice UPS accessory devices 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 (medical device) where injury has not yet been reported, and the potential hazards include chemical exposure and fire risks.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 71 units of GEMINI TF PET/CT 64 Slice 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 firm was notified that 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 # 882471 and specific serial numbers listed in the agency documentation.
The affected devices were distributed worldwide, including the United States (nationwide, DC, and Puerto Rico) and numerous international locations. Consumers and healthcare facilities should contact the recalling firm for instructions on how to address the defective accessory devices.
The recalled product
- Product
- GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 71
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 #: 882471
- Serial #s: 7037
- 7205
- 7206
- 7209
- 7212
- 7213
- 7214
- 7217
- 7218
- 7219
- 7221
- 7227
- 7229
- 7231
- 7234
- 7238
- 7241
- 7245
- 7251
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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