Recall record at a glance
| Official record | Z-1507-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Philips North America |
| Report date | Apr 17, 2024 |
| Recall initiation date | Dec 24, 2020 |
| Quantity | 428 units |
| Location | Cambridge, MA, United States |
Official product description
PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-sectional images of the body Model Number: 728143
Why the product was recalled
Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide with the moved tabletop and be injured
Distribution information
Nationwide including Puerto Rico Foreign: Albania Argentina Australia Austria Bangladesh Bolivia Brazil Bulgaria China Czech Republic Denmark Ecuador Egypt France Germany Greece Hungary India Indonesia Iraq Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Kuwait Latvia Lebanon Libya Malaysia Myanmar Nepal Netherlands Norway Pakistan Palestine, State of Peru Philippines Poland Puerto Rico Qatar R¿union Romania Russian Federation Saudi Arabia Senegal Serbia Spain Sweden Switzerland Thailand Tunisia Turkey United Arab Emirates United Kingdom Uzbekistan Viet Nam
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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