Recall record at a glance
| Official record | Z-1265-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Philips North America LLC |
| Report date | Mar 24, 2021 |
| Recall initiation date | Feb 22, 2021 |
| Quantity | 105 units (1 US and 104 OUS) |
| Location | Cambridge, MA, United States |
Official product description
Incisive CT Computed Tomography X-ray System Model: 728143
Why the product was recalled
Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuators fail. In some cases in systems with affected components, the gantry may tilt forward slowly, in a worst case, reaching to the tilt limit angle +31degrees
Distribution information
US Virgin Island Foreign: Australia Bolivia China Germany Hungary Indonesia Italy Japan Korea Korea, Republic of Latvia Palestine Philippines Romania Russian Federation Senegal Thailand Uzbekistan
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: E-Mail.
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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