Recall record at a glance
| Official record | Z-1207-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Carestream Health, Inc. |
| Report date | May 1, 2019 |
| Recall initiation date | Mar 19, 2019 |
| Quantity | 37 units |
| Location | Rochester, NY, United States |
Official product description
OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric patients aged 12 and over.
Why the product was recalled
When the user performs the re-assignment of a parent / companion pair, the parent volume is transferred to the new patient but the companion volume will remain in the original patient s exam.
Distribution information
Worldwide Distribution: US (nationwide) to states of: Arizona, California, New York, Alabama, Georgia, Georgia, Illinois, Minnesota, New York, Oregon, Pennsylvania; and countries of: IRAN, ITALY, JERUSALEM, KOREA, PHILIPPINES, PORTUGAL,SAUDI ARABIA, SINGAPORE, SWITZERLAND THAILAND, and UNITED KINGDOM.
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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