Vue Motion V12 may display cine image frames out of sequence
Philips is recalling Vue Motion V12 because mis-ordered frames during dynamic cine runs may cause image frames to display out of sequence.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: diagnostic image frames may be presented out of order to a reviewing clinician, and no injuries are stated in the source.
Plain-English summary
Vue Motion V12, product number 1017979, is being recalled. About 3,552 units were distributed nationwide in the United States and to more than seventy other countries. The FDA has classified this recall as Class II.
There is potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause image frames to display out of sequence.
Affected product is identified by product number 1017979.
Facilities can identify affected installations by the product number above, and may contact the recalling firm for further information.
The recalled product
- Product
- Vue Motion V12. Product Number: 1017979.
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Affected units
- 3,552
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)
- Product Number: 1017979
- (01)00884838100367(11)230223(10)12.2.8.300
- (01)00884838100343(11)200423(10)12.2.5.0
- (01)00884838100367(11)230615(10)12.2.8.310
- (01)00884838100367(11)200903(10)12.2.5.1
- (01)00884838100367(11)230720(10)12.2.8.400
- (01)00884838100343(11)201125(10)12.2.5.100
- (01)00884838100367(11)230921(10)12.2.8.410
- (01)00884838100343(11)210217(10)12.2.5.200
- (01)00884838100336(11)231221(10)12.2.8.420
- (01)00884838100367(11)210628(10)12.2.5.300
- (01)00884838100350(11)240116(10)12.2.8.421
- (01)00884838100350(11)240204(10)12.2.8.422
- (01)00884838100343(11)220525(10)12.2.5.400
- (01)00884838100350(11)240226(10)12.2.8.424
- (01)00884838100367(11)230223(10)12.2.5.405
- (01)00884838100336(11)230301(10)12.2.5.406
- (01)00884838100367(11)230320(10)12.2.5.407
- (01)00884838100367(11)230403(10)12.2.5.408
- (01)00884838100367#(11)231223(10)12.2.8.435
Distribution
Distributed nationwide across the United States.
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