The Oncology Essentials Package of the Spectral CT imaging system.
Reported: May 8, 2024 Initiated: March 29, 2024 #Z-1756-2024
Product Description
The Oncology Essentials Package of the Spectral CT imaging system.
Reason for Recall
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.
Details
- Recalling Firm
- Philips North America Llc
- Units Affected
- 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.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
The Oncology Essentials Package of the Spectral CT imaging system.. Recalled by Philips North America Llc. Units affected: 12 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 8, 2024. Severity: Moderate. Recall number: Z-1756-2024.
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