Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
Summary
The FDA issued a Class II for Incisive CT, model 728143 & 728144 running Software Version 5.0.0. by Philips Healthcare (Suzhou) Co., Ltd.. Reason: Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need fo.
Details
Source
Device Recall
External ID
Z-0640-2024
Action Date
2024-01-17
Status
Ongoing
Category
device
Product Description
Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
Lot/Code Info: UDI-DI: 00884838085015 (Model 728143) UDI-DI: 00884838105508 (Model 728144)
Quantity Affected: 828
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-23
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips Healthcare (Suzhou) Co., Ltd. has 12 FDA actions in our database, including 2 recalls and 10 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips Healthcare (Suzhou) Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips Healthcare (Suzhou) Co., Ltd. have FDA actions?
Philips Healthcare (Suzhou) Co., Ltd. has 12 FDA actions in our database, including 2 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0640-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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