—#160820

Product

Philips Healthcare IQon Spectral CT computed tomography x-ray system

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K133674
Affected lot / code info: IQon Spectral CT 728332 Devices manufactured 03/05/2009 to present.

Why it was recalled

There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.

Root cause (FDA determination)

Device Design

Action the firm took

Philips Healthcare is informing consignees of this issue through a Customer Information Letter (CIL_FCO72800690). Philips Key Market representatives will distribute the letter internationally, based on local regulations. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. Customers are notified that if they hear an unusual noise coming from the gantry, or scan halts, the Philips representative should be contacted as soon as possible. Philips will be inspecting the affected systems, tightening and replacing the reaction ring screws as needed at no additional cost.

Recalling firm

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

Distribution

Distribution pattern: 107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts

Timeline

Recall initiated: 2017-11-08
Terminated: 2020-04-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #160820. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.