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Terminated

Ingenuity Core128 728323

FDA Recall Z-2275-2018 · Posted None

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2018-03-28
Date Terminated2020-04-21
Product Quantity28 total

Reason for Recall

A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.

Firm Action

Urgent Field Safety Notice letters were sent to customers on 3/28/18. The letters did not request any actions to be conducted by the customers. For Brilliance Big Bore/ Ingenuity CT / Ingenuity Core / Ingenuity Corel 28 Customers: A Philips Field Service Engineer will contact you to schedule the FCO updates at your site. Field Change Order (FCO 72800691 and 72800692) will be released to correct the issue. For Ingenuity TF PET/CT Customers: Field Change Order (FCO 88200520 and 88200511) will be released to correct this issue. A Philips Field Service Engineer will contact you to schedule the FCO updates at your site.

Root Cause

Other

Distribution Pattern

The systems were distributed to the following US states: HI, KS, and MO. The systems were distributed to the following foreign countries: Algeria, Austria, Brazil, China, Indonesia, Japan, Kenya, Korea, Mexico, Poland, Turkey, and Uganda.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K160743Philips Ingenuity CTPhilips Medical Systems (Cleveland), Inc. · 2016-08-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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