—#161069

Product

Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K052640
Affected lot / code info: Ingenuity TF PET/CT Model # 882442

Why it was recalled

One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.

Root cause (FDA determination)

Vendor change control

Action the firm took

Philips Healthcare is notifying the affected users of this issue via this Customer Information Letter and correcting via Field Change Order FC088200514.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: One domestic and 1 foreign consignee ( Spain)

Timeline

Recall initiated: 2017-11-01
Terminated: 2018-08-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161069. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.