Brilliance Big Bore (Oncology) - Model no. 728243, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial No: 75070 750002 75046 750002 75114 75118 75127 75130 750021 75128 750015 75052 75039 75027 75067 75041 75028 75036 75034 75029 75031 75047 75048 75057 75054 75049 75056 75053 75058 75062 75064 75066 75068 76023 75037 76022 76024 75104 75111 75126 75112 750006 76008 750014 75059 750005 75061 75107 750007 750008 75129 750013 75120 750028 750016 750022 750024 750025 750026 750029 75115 75131 750023 7524 75119 76002 75121 75108 75102 75101 75108 75100 750004 75132 750019 750020 75063 75044 750001 75113 750012 75035 75038 75051 75051 750010 750017 75055 75060 75055 750027 75105 75042 75032 75069 75040 75116 75065 75050 75065 76011 76010 76016 76020 76021 750018
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Philips Medical Systems (Cleveland) Inc
- Reason for Recall:
- Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Brilliance Big Bore (Oncology) - Model no. 728243, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Product Codes/Lot Numbers:
Serial No: 75070 750002 75046 750002 75114 75118 75127 75130 750021 75128 750015 75052 75039 75027 75067 75041 75028 75036 75034 75029 75031 75047 75048 75057 75054 75049 75056 75053 75058 75062 75064 75066 75068 76023 75037 76022 76024 75104 75111 75126 75112 750006 76008 750014 75059 750005 75061 75107 750007 750008 75129 750013 75120 750028 750016 750022 750024 750025 750026 750029 75115 75131 750023 7524 75119 76002 75121 75108 75102 75101 75108 75100 750004 75132 750019 750020 75063 75044 750001 75113 750012 75035 75038 75051 75051 750010 750017 75055 75060 75055 750027 75105 75042 75032 75069 75040 75116 75065 75050 75065 76011 76010 76016 76020 76021 750018
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1410-2018
Related Recalls
Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Philips Medical Systems (Cleveland)
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Philips Medical Systems (Cleveland)
When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen.