Philips Spectral CT Oncology Imaging System Recall: Laser Reflection Hazard
Philips recalls 12 units of its Spectral CT Oncology Essentials system because a marking laser could reflect off the gantry cover, potentially causing misdiagnosis and incorrect patient treatment.
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: This is an FDA Class II recall of a diagnostic imaging device used in oncology. The hazard is a potential laser reflection that could lead to misdiagnosis and incorrect treatment. No illnesses, injuries, or misdiagnoses have been reported. Per the severity rubric, a score of 3 (High) applies to risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America Llc is recalling 12 units of the Oncology Essentials Package of its Spectral CT imaging system. The affected units have model number 728333 and the following serial numbers: 10069, 10084, 10169, 10137, 10163, 10196, 10181, 10199, 10210, 10206, 10202, 10139.
A marking laser used with the device can potentially reflect off the gantry cover surface. This reflection could lead to misdiagnosis and subsequent incorrect treatment of patients.
The affected units have been distributed worldwide, including healthcare facilities in Arizona, Hawaii, Minnesota, Vermont, West Virginia, as well as China, Macao, New Zealand, Portugal, and Switzerland.
Facilities using affected units should contact Philips North America Llc to verify whether their device serial number is included in this recall and for further guidance.
The recalled product
- Product
- The Oncology Essentials Package of the Spectral CT imaging system.
- Manufacturer
- Philips North America Llc
- Affected units
- 12
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 (14)
- Model No. 728333
- UDI: (01)00884838101111(21)
- Serial No. 10069
- 10084
- 10169
- 10137
- 10163
- 10196
- 10181
- 10199
- 10210
- 10206
- 10202
- 10139.
Distribution
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