FDA Medical Device Recalls (openFDA)
Philips North America Llc: 728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
- Recall number
- Z-2316-2021
- Recalling firm
- Philips North America Llc
- Product
- 728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
- Status
- Terminated
- Initiated
- 2021-06-08
- Posted
- not on file
- Terminated
- 2023-08-10
- Reason
- When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
- Root cause
- Software design
- Action
- Philips issued Urgent Medical Device Correction letter dated 6/8/21 to consignees via certified mail. Letter states reason for recall, health risk and action to take: following steps: Go to Preferences> Regional Settings > Weight units, select the Weight units to Kg. Step 1: Verify that the patient weight unit is set to Kg, rather than Lbs. Step 2: Change the weight unit to Kg if weight unit is set to Lbs, referring to the screenshot below Step 3: Log out and then log back in to make the changes effective. Please share this notice with all those who need to be aware within your organization. Please complete and return the attached response form to Philips Healthcare promptly upon receipt and no later than 30 days from receipt, via email to CTNM.QARA@PHILIPS.COM The software update is planned to be released in the 3rd quarter of 2021. Once the software update is released, a Philips representative will contact you to schedule a software update to permanently resolve the issue. For North America, contact the Customer Care Solutions Center (1-800-722-9377).
- Quantity
- 3 units
- Distribution
- US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.
- Lot, serial or model codes
- Serial Number: 300099 300106 300143 Software Version 4.1.10 SynchRight Option
- 510(k) numbers
- ["K160743"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 3016618143
- 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