FDAClass IIJuly 3, 2013

Brilliance CT 64 recall

Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce…

Why was Brilliance CT 64 recalled?

If the operator selects a patient name from the worklist using the mouse and then selects a different patient name using the keyboard (arrow keys then press enter) the patient name that populates the exam information page is the patient name selected with the mouse. Also, it is possible to begin a normal clinical scan while the anti-virus scan is running. However, if the user is running a bol

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

The following codes are affected by this recall:System Code #728231, Serial #: 9654, 91003, 95130, 95157, 95504 System Code #728326, Serial #: 32000,300003,300004,300005,300010,300011,300012,300013, 300014,300015,300018, 300027,300041,300053,300054, 300059, 300066, 300070,300071, 300073, 300074, 30077, 300078, 300079, 300080,300082,300084,300086,300091,300092, 300095, 300101, 300102,300112, 300119, 300127, 300128, 300129, 300131, 300132, 310064, 320030 System Code #728321, Serial #: 310096, 310070 System Code #728323, Serial #: 320033

Product
Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce…
Recalling firm
Philips Medical Systems (Cleveland) Inc
Quantity
50 units
Distribution
Nationwide Distribution-including the states of AR, AZ, DE, IN, KS, LA, MA, MN, MS, MT, NJ, NY, NY, OH, OR, PA, TN, TX, VT, WV, and WY.
Recall date
July 3, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls