Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product Usage: intended for use in the head and whole body.
FDA Recall Z-1273-2021 · Posted None
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Recalling FirmPhilips Healthcare (Suzhou) Co., Ltd.
Recall StatusTerminated
Product CodeJAK
Date Initiated2021-02-24
Date Terminated2023-02-17
Product Quantity109 systems
Reason for Recall
Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly downward to its limit position.
Firm Action
On 2/18/2021, Philips issued an Urgent Medical Device Correction because the firm has detected an issue with some actuators used in the couch of Incisive CT and Access CT systems, which could result in the couch unexpectedly moving slowly downward to its limit position.
Root Cause
Process control
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of KY, FL, St. Croix, and the countries of Australia, Bolivia, China, Germany, Hungary, Italy, Japan, Republic of Korea, Latvia, Palestine, Puerto Rico, Romania, Russia, Saudi Arabia, Senegal, Serbia, Spain, Sweden, Thailand, Uzbekistan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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