Terminated

Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059559(21)900006 (01)00884838059559(21)900007 (01)00884838059559(21)900008 (01)00884838059559(21)900009 (01)00884838059559(21)900010 (01)00884838059559(21)900011 (01)00884838059559(21)900012 (01)00884838059559(21)900013 (01)00884838059559(21)900014 (01)00884838059559(21)900015 (01)00884838059559(21)900016 (01)00884838059559(21)900017 (01)00884838059559(21)900018 (01)00884838059559(21)900019 (01)00884838059559(21)900020 (01)00884838059559(21)900021 (01)00884838059559(21)900022 (01)00884838059559(21)900023 (01)00884838059559(21)900024 (01)00884838059559(21)900025 (01)00884838059559(21)900026 (01)00884838059559(21)900027 (01)00884838059559(21)900028 (01)00884838059559(21)900029 (01)00884838059559(21)900030 (01)00884838059559(21)900031 (01)00884838059559(21)900032 (01)00884838059559(21)900033 (01)00884838059559(21)900034 (01)00884838059559(21)900035 Product Usage: The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.

FDA Recall Z-2496-2018 · Posted None

Recalling FirmPhilips Medical Systems (Cleveland) Inc

Recall StatusTerminated

Product CodeKPS

Date Initiated2018-05-21

Date Terminated2020-04-10

Product Quantity32 units

Reason for Recall

The block used to connect the patient pallet to the couch may be assembled incorrectly. A screw may be misaligned in the patient pallet.

Firm Action

On May 21, 2018, Philips issued Customer Information notices to their clients. A Philips Field Service Engineer will contact customers directly to schedule the updates at your specific site. If you need any further information or support concerning this issue, please contact your local Philips representative. For SUPPORT in North America and Canada, contact the Customer Care Solutions Center 1-800-722-9377, follow prompts.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of CA, GA, LA, MD, MI, NY, OH, TN, TX, VT, Washington DC & WI Internationally - Canada, Mexico, Belgium, France, Israel, Luxembourg, Netherlands, Singapore, Spain & Switzerland

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123599INGENUITY DIGITAL PET/CTPhilips Healthcare (Cleveland) · 2013-07-12

Official Source

View FDA Recall →

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