—#160621

Product

Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K060937
Affected lot / code info: Brilliance iCT 4.1.6 version. Brilliance iCT SP - Model 728311 Codes: 200038 200203 200119 200052 200206 200210 200208 200213 200097 200100 200063 200009 200011 200204 200212 200018 200207 200027 200130 83001 200209 200215 200043 200032 200200 200051 200086 200202 200211 200024 200023 200068 200201 200017 200061 200205 200030 200117 200044 200015 83000 200022 200093 200101 200040 200013 200107 200111 200138 200214 200102 200047 200019 200105 200109 200121 200041 200131 200127 200003 200092 200074 200088 200067 200089 200049

Why it was recalled

Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.

Root cause (FDA determination)

Software design

Action the firm took

A Customer Information Letter dated June 29, 2017, was sent to US consignees via certified mail. 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.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution, including US nationwide.

Timeline

Recall initiated: 2017-07-11
Terminated: 2019-07-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #160621. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.