FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Ingenuity TF PET/CT. Diagnostic imaging system
- Recall number
- Z-0897-2013
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Ingenuity TF PET/CT. Diagnostic imaging system
- Status
- Terminated
- Initiated
- 2013-01-21
- Posted
- 2013-02-28
- Terminated
- 2013-07-19
- Reason
- The system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients.
- Root cause
- Software design
- Action
- Philips Medical Systems (Cleveland), Inc. sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated January 21, 2013 to the affected customer. The letter identified the product, problem, and actions to be taken by the customer. Contact your local Philips representative or Philips Healthcare office for further information concerning this issue.
- Quantity
- 1 Unit
- Distribution
- Distributed only in Ohio.
- Lot, serial or model codes
- Model # 882456, Serial # 2004. Units currently running Ingenuity TF PET/CT system software version 4.0.0.26635.
- 510(k) numbers
- ["K052640"]
- PMA numbers
- not on file
- Product code
- KPS
- 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