Recall record at a glance
| Official record | Z-1846-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Brainlab AG |
| Report date | Jun 16, 2021 |
| Recall initiation date | May 14, 2021 |
| Quantity | 22 systems in the U.S. |
| Location | Munich, N/A, Germany |
Official product description
ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Why the product was recalled
Display of potential patient movement might be delayed to the user for high dose treatments.
Distribution information
US Nationwide distribution in the states of AZ, AR, CA, FL, IN, NJ, NY, NC, OR, PA, and TX. There was no government/military distribution.
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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