Recall Z-0733-2022 ยท IYE Accelerator, Linear, Medical
Brainlab AG
ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.
| Date | Feb 25, 2022 |
| Status | Open, Classified |
| Reason | The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs. |
| Root cause | Software design |
| Action | The recalling firm initiated the recall via email on 2/25/2022 with the Urgent Field Safety Notice dated 2/7/2022 attached. The email says to ensure the safe and effective use of the device, the consignee is to reply (1) they have received the Field Safety Notice; (2) the affected device is installed at the hospital and the the addressee of the email is the correct recipient for the communication; and (3) users at the hospital have been made aware of the content and adhere to the User Corrective Action described in the enclosed notification. The email asks the consignee to answer each of th |
| Quantity | 205 systems |
| Distribution | Distribution was made to AZ, AR, CA, CO, FL, GA, IN, KY, MD, MS, MO, NJ, NY, NC, OK, OR, PA, TX, VA, and WA. There was no government or military distribution. Foreign distribution was made to Australia, Austria, Bahrain, Belgium, China, Denmark, France, Germany, Hong Kong, India, Ireland, Israel, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211939 | ExacTrac Dynamic Brainlab AG, Jul 22, 2021 |