Philips Medical Systems (Cleveland) Inc Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1)
Brand
Philips Medical Systems (Cleveland) Inc
Lot Codes / Batch Numbers
Serial numbers 7009, 7056, 7060, 7066, 7069, 7072, 7079, 7088, 7111, 7112, 7113, 7114, 7117, 7118, 7119, 7121, 7125.
Products Sold
Serial numbers 7009, 7056, 7060, 7066, 7069, 7072, 7079, 7088, 7111, 7112, 7113, 7114, 7117, 7118, 7119, 7121, 7125.
Philips Medical Systems (Cleveland) Inc is recalling Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1) due to Two conditions have been identified with the Philips Medical System Brilliance Bore ,version 2.2.1 Tumor Localization, that may lead the user to misin. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Two conditions have been identified with the Philips Medical System Brilliance Bore ,version 2.2.1 Tumor Localization, that may lead the user to misinterpret the displayed data.
Recommended Action
Per FDA guidance
Customer advisory notification letters dated 10/4/06 and 10/25/06 were sent to consignees providing short term work around instructions. Software modifications installed by the recalling firm will follow as the long term correction.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026