FDA Medical Device Recalls (openFDA)
Philips North America: Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
- Recall number
- Z-1958-2026
- Recalling firm
- Philips North America
- Product
- Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
- Status
- Open, Classified
- Initiated
- 2026-04-14
- Posted
- 2026-04-27
- Terminated
- not on file
- Reason
- The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- Root cause
- Under Investigation by firm
- Action
- Philips Medical notified consignees on about 04/14/2026 via letter. Consignees were made aware of the issue, affected units, and instructed to continue to use MDE as per established guidelines, manually update the scan protocol settings according to the directions provided to prevent the issue from occurring, and continue using the systems in accordance with their intended use. Consignees were also instructed to circulate the notice to all users for awareness, retain the Urgent Medical Device letter with affected systems until the software upgrade is installed and complete and return the provided response form.
- Quantity
- 64 units
- Distribution
- Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.
- Lot, serial or model codes
- 1. Model Number (REF): 781342. UDI: (01)00884838055339(21)71693, (01)00884838055339(21)71581, (01)00884838055339(21)71582, (01)00884838055339(21)71607, (01)00884838055339(21)85216, (01)00884838055339(21)71106, (01)00884838055339(21)71477, (01)00884838055339(21)71512, (01)00884838055339(21)71966, (01)00884838055339(21)71967, (01)00884838055339(21)85147, (01)00884838055339(21)85224, (01)00884838055339(21)85318, (01)00884838055339(21)71462, (01)00884838055339(21)71619, (01)00884838055339(21)85250, (01)00884838055339(21)71002, (01)00884838055339(21)71037, (01)00884838055339(21)71269, (01)00884838055339(21)71841, (01)00884838055339(21)71885, (01)00884838055339(21)71897, (01)00884838055339(21)85126, (01)00884838055339(21)85109, (01)00884838055339(21)71296, (01)00884838055339(21)71188, (01)00884838055339(21)71088, (01)00884838055339(21)71387, (01)00884838055339(21)71799, (01)00884838055339(21)71040, (01)00884838055339(21)71344, (01)00884838055339(21)71583, (01)00884838055339(21)71916, (01)00884838055339(21)71368, (01)00884838055339(21)71756, (01)00884838055339(21)71822, (01)00884838055339(21)71459, (01)00884838055339(21)71022, (01)00884838055339(21)71185, (01)00884838055339(21)71286, (01)00884838055339(21)71378, (01)00884838055339(21)71646, (01)00884838055339(21)71732, (01)00884838055339(21)71612, (01)00884838055339(21)71340, (01)00884838055339(21)71336. Serial Numbers: 71693, 71581, 71582, 71607, 85216, 71106, 71477, 71512, 71966, 71967, 85147, 85224, 85318, 71462, 71619, 85250, 71002, 71037, 71269, 71841, 71885, 71897, 85126, 85109, 71296, 71188, 71088, 71387, 71799, 71040, 71344, 71583, 71916, 71368, 71756, 71822, 71459, 71022, 71185, 71286, 71378, 71646, 71732, 71612, 71340, 71336. 2. Model Number (REF): 781377. UDI: (01)00884838009813(21)42305, (01)00884838009813(21)42097, (01)00884838009813(21)42364, (01)00884838009813(21)42136, (01)00884838009813(21)42237, (01)00884838009813(21)42455, (01)00884838009813(21)42087, (01)00884838009813(21)42401, (01)00884838009813(21)42321, (01)00884838009813(21)42001, (01)00884838009813(21)42036, (01)00884838009813(21)42053, (01)00884838009813(21)42126, (01)00884838009813(21)42400. Serial Numbers: 42305, 42097, 42364, 42136, 42237, 42455, 42087, 42401, 42321, 42001, 42036, 42053, 42126, 42400. 3. Model Number (REF): 782103. UDI: (01)00884838098299(21)85672, (01)00884838098299(21)85673, (01)00884838098299(21)85674, (01)00884838098299(21)85646. Serial Numbers: 85672, 85673, 85674, 85646.
- 510(k) numbers
- ["K223458","K251397","K251808"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 3006648320
- Firm city
- Cambridge
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28