Ingenia Ambition X systems recalled over elastography stiffness value errors
Philips North America is recalling 21 units of the Ingenia Ambition X because exported MR Elastography stiffness maps may show stiffness value errors.
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 exported elastography maps may show incorrect stiffness values, and no injuries are reported.
Plain-English summary
The Philips Ingenia Ambition X, product codes 781356, 782109 and 782138, covering MR systems with software versions R11.1 and R12.1, is being recalled by Philips North America.
The reason given in the enforcement record is the potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps in a viewer Picture Archiving and Communication System (PACS).
The record lists 21 units, with UDI-DI codes and serial numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States across the states listed in the record. The FDA has classified the action as Class II.
An incorrect stiffness value is a measurement a clinician reads. The enforcement record reports no injuries. Facilities should follow Philips' instructions.
The recalled product
- Product
- Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI
- Affected units
- 21
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 (20)
- MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781356
- UDI-DI: 00884838090040
- Serial Numbers: 47206
- 47038
- 47068
- 47260
- 47294
- 47029
- 47189. (2) Product Code (REF): 782109
- UDI-DI: 00884838098350
- Serial Numbers: 47849
- 47634
- 47534
- 47726
- 47760
- 47706
- 47789
- 47642
- 47681
- 47761
Distribution
Part of a larger recall action
This product is one of 13 recalled by Philips North America 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.
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