The Oncology Essentials Package of the Spectral CT recall
The Oncology Essentials Package of the Spectral CT imaging system.
Why was The Oncology Essentials Package of the Spectral CT recalled?
Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No. 728333; UDI: (01)00884838101111(21); Serial No. 10069, 10084, 10169, 10137, 10163, 10196, 10181, 10199, 10210, 10206, 10202, 10139.
- Product
- The Oncology Essentials Package of the Spectral CT imaging system.
- Recalling firm
- Philips North America Llc
- Quantity
- 12 units
- Distribution
- Worldwide distribution - US Nationwide in the states of AZ, HI, MN, VT, WV and the countries of China, Macao, New Zealand, Portugal, Switzerland.
- Recall date
- May 8, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)