Recall Z-0640-2024— Philips Healthcare (Suzhou) Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by Philips Healthcare (Suzhou) Co., Ltd., initiated 2022-12-23. It names 2 FDA 510(k) clearances: K212441, K180015. Product: Incisive CT, model 728143 & 728144 running Software Version 5.0.0.. Reason: 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..
- Recalling firm
- Philips Healthcare (Suzhou) Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-12-23
- Firm location
- Suzhou, China
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.