FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
- Recall number
- Z-2491-2015
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
- Status
- Terminated
- Initiated
- 2015-07-23
- Posted
- 2015-08-31
- Terminated
- 2018-06-26
- Reason
- Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruction Server (PRS) database may lock up after an MR acquisition is completed and before a PET acquisition is begun, even though no actual database lockup issue has been reported in the field-installed Ingenuity TF PET/MR systems.
- Root cause
- Software design
- Action
- On July 23, 2015 the firm sent Field Safety Notices to their customers.
- Quantity
- 11
- Distribution
- Product was shipped to the following states: NY, OH & TX. Product was also shipped to the following countries: Finland, Germany, Hong Kong, Japan, Netherlands, South Korea, Spain & Switzerland.
- Lot, serial or model codes
- M/N 882380; S/N: 11005, 11006, 11007, 11008, 11009, 11010, 11011, 11012, 11013, 11014 & 24061.
- 510(k) numbers
- ["K103483"]
- PMA numbers
- not on file
- Product code
- OUO
- Firm FEI
- 1525965
- Firm city
- Cleveland
- Firm state
- OH
- 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