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Incisive CT recallZ-0640-2024 · Philips Healthcare (Suzhou) Co., Ltd. · initiated Dec 23, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips Healthcare (Suzhou) Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occur on perfusion images, 2. Orientation label reversed in 2D images, 3. Auto voice does not work during the cardiac scan, 4. Auto voice and operators voice are too quiet, patient cant hear, 5. Not all of the images are reconstructed in some cases, 6. No image displayed on the console monitor after enabling CCT Single Scan, 7. Ring artifact appears in 32x0.625 collimation of bone scan when soft tissue view is selected, 8. A design defect where the error couch motion signal of couch firmware causes couch to identify current position as target position in next protocol, and 9. calcium scoring study split into separate series after loading to ISP.

FDA root cause category: Software design

What the company is doing

Philips issued an Important Product Notice regarding software issues on Philips Incisive CT systems (reference FCO72800790) dated December 23, 2022 via USPS mail. Customers are instructed to continue to use your system(s) in accordance with the intended use. 1) Refer to Appendix A of the letter for specific details regarding the issue descriptions, and advice on actions to be taken. Philips Field Service Engineer will contact you to schedule the installation of the software upgrade (FCO72800790). 2) Circulate this notice to all users of this device so that they are aware of the issues. 3) Please retain the letter with your system(s) until a software solution is installed; ensure the notice is in a place likely to be seen/viewed. 4) Complete and return the attached Important Product Notice Acknowledgement Form to Philips. Contact Philips Customer Care Solutions Center with questions at (800)-722-9377.

Recall details

Recall number
Z-0640-2024
Status
Open, Classified
Initiated by the company
Dec 23, 2022
Posted by the FDA
Jan 5, 2024
Recalling firm
Philips Healthcare (Suzhou) Co., Ltd.
Quantity
828
Product code
JAK
FDA submissions
K212441, K180015
Distribution
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VT, WI, & Puerto Rico and the countries of Albania, Algeria, Argentina, Australia, Austria, Bhutan, Bolivia, Bosnia-Herz, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Ethiopia, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Mauritius, Moldova, Morocco, Netherlands, New Zealand, Norway, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Rwanda, Saint Kitts, Saint Lucia, Saudi Arabia, Senegal, Serbia, Sint Maarten, Slovakia, South Africa, South Korea, Spain, St. Pier Miquel, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, United Arab Emirates, Uzbekistan, Venezuela, & Vietnam.

Product description

Incisive CT, model 728143 & 728144 running Software Version 5.0.0.

Code information (models, lots, serial numbers)

UDI-DI: 00884838085015 (Model 728143) UDI-DI: 00884838105508 (Model 728144)

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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