Z-2496-2018 Class II Terminated
FDA device recall Z-2496-2018 was initiated by Philips Medical Systems (Cleveland) Inc on May 21, 2018 and is designated Class II. 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. The recall status is terminated (terminated Apr 10, 2020). Affected quantity: 32 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 25, 2018
- Initiation Date
- May 21, 2018
- Termination Date
- Apr 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 units
Product Description
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.
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.
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
Code Information
Serial Numbers: 900004 900005 900006 900007 900008 900009 900010 900011 900012 900013 900014 900015 900016 900017 900018 900019 900020 900021 900022 900023 900024 900025 900026 900027 900028 900029 900030 900031 900032 900033 900034 900035
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2496-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026