FDA Recall Terminated

Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848

Recall: Z-1921-2020 · Initiated April 6, 2020

Recall

Recall Number: Z-1921-2020
Event Number: 85513
Firm: Philips North America, LLC
FEI Number: 1218950
Product Code: JAK
Status: Terminated
Root Cause: Process control
Initiated: April 6, 2020
Posted: May 6, 2020
Terminated: September 16, 2022
Address: 3000 Minuteman Rd, Andover, MA, 01810-1032

Description

Reason

The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.

Action

Philips sent a Medical Device Correction-Urgent Field Safety Notice dated April 6, 2020 to all affected customers. The firm instructed customers to review the information with all members of the staff who need to be aware of the contents of the notice and to maintain a copy with the equipment in the Instructions for Use. Customers were directed to complete and return the form stating that they received, read, and understood the contents of the letter and have taken appropriate actions. URGENT - Field Safety Notice Medical Device Correction letter dated 5/20/20 was sent to customers informing them of two additional affected systems. There is no action required by the customer. Testing and engineering analysis demonstrate that the under-torqued bolts do not pose any immediate safety risk as the mechanical connection between the cooling unit and the rotor continues to meet applicable safety standards. The affected systems may continue to be used according to the IFU. Philips is distributing this FSN to all affected customers/users and will correct the issue via Field Change Order FCO 72800725. Urgent Field Safety Notice Medical Device Correction dated 5/20/20 was distributed to notify additional systems not previously included in the original notification. There is no action required by the customer. Testing and engineering analysis demonstrate that the under-torqued bolts do not pose any immediate safety risk as the mechanical connection between the cooling unit and the rotor continues to meet applicable safety standards. The affected systems may continue to be used according to the IFU. Philips is distributing this FSN to all affected customers/users and will correct the issue via Field Change Order FCO 72800725. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts).

Distribution

Worldwide distribution including one unit distributed to Iowa.

Quantity