Azurion 3 M12 systems recalled over tables that may move unexpectedly
Philips is recalling 291 units of the Azurion 3 M12 because the table may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.
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: Scored 3 under the risk-of-harm criterion: the firm states the table may move unexpectedly even with a lock active, and no injuries are reported.
Plain-English summary
The Philips Azurion 3 M12, covering system model numbers 722063, 722221 and 722229, on all software versions R1.X, R2.X and R3.X, is being recalled by Philips Medical Systems Nederland B.V.
The reason given in the enforcement record is that under certain conditions the table may move unexpectedly when the Reset Geometry button is pressed, even when a table lock is active.
The record lists 291 units, of which 27 are in the US and 264 outside it, with UDI-DI codes recorded in the enforcement record. Distribution was worldwide, covering the United States nationwide and the countries listed in the record. The FDA has classified the action as Class II.
An unexpected table movement during a procedure is a risk to the patient and staff. The enforcement record reports no injuries. Facilities should follow Philips' instructions.
The recalled product
- Product
- Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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 (7)
- System Model Numbers: (1) 722063
- (2) 722221
- (3) 722229
- UDI-DIs: (1) 884838085275
- (2) 884838099203
- (3) 884838116726
- Serial Numbers: All
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
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