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

FDA device recall Z-0640-2024 · posted 2024-01-05 · Open, Classified

Recall details

Recalling firm

Philips Healthcare (Suzhou) Co., Ltd.

Reason for recall

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.

Action taken

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.

Root cause

Software design

Status

Open, Classified

Product code

JAK

Quantity affected

828

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

Date initiated

2022-12-23

Date posted

2024-01-05

Location

Suzhou, Pingjiang, China

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