Zenition 50 & 70 Mobile Surgery C-arm recall
Zenition 50 & 70 Mobile Surgery C-arm
Why was Zenition 50 & 70 Mobile Surgery C-arm 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.
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?
Zenition 50 974 Zenition 50 1244 Zenition 50 1247 Zenition 50 892 Zenition 70 1735 Zenition 70 1824
- Product
- Zenition 50 & 70 Mobile Surgery C-arm
- Recalling firm
- Philips North America
- Distribution
- United States Territories of Puerto Rico, Guam, and Virgin Islands
- Recall date
- November 15, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)