Zenition 50 & 70 Mobile Surgery C-arm
Reported: November 15, 2023 Initiated: October 4, 2023 #Z-0226-2024
Product Description
Zenition 50 & 70 Mobile Surgery C-arm
Reason for Recall
Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
Details
- Recalling Firm
- Philips North America
- Distribution
- United States Territories of Puerto Rico, Guam, and Virgin Islands
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
Zenition 50 & 70 Mobile Surgery C-arm. Recalled by Philips North America.
Why was this product recalled? ▼
Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 15, 2023. Severity: Moderate. Recall number: Z-0226-2024.
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