Recall Z-0710-2020
Angiodynamics, Inc. · initiated November 19, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body.
Codes / lots: Lot Numbers: 025-001-055-A-003, 025-001-055-A-005, 025-001-055-A-007, 025-001-055-A-008 UDI: 00851546007196
Reason for recall
May result in readings outside of the expected accuracy range.
FDA-determined cause: Under Investigation by firm
Action taken
AngioDynamics issued Urgent Medical Device Correction Letter on November 19, 2019, via Federal Express. The letter states reason for recall , health risk and action to take: Stop using the product subject to recall. o Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). Segregate and return all affected devices to AngioDynamics, Inc. Consignees are directed to complete and return the Reply Verification Tracking Form, provided in the recall notification. cCall AngioDynamics Customer Service at 1-800- 772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain an RMA for your returned product.
Details
- Recall number
- Z-0710-2020
- Initiated
- November 19, 2019
- Terminated
- October 26, 2020
- Product code
- NZT – Dosimeter, Ionizing Radiation, Implanted
- Quantity
- 4 units
- Distribution
- US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA.
- Recalling firm
- Angiodynamics, Inc., Queensbury, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0709-2020 Class II | OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F -…May result in readings outside of the expected accuracy range. | 11/19/2019Terminated |
| Z-0711-2020 Class II | MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated PSD sensors…May result in readings outside of the expected accuracy range. | 11/19/2019Terminated |
| Z-0712-2020 Class II | MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD sensors are…May result in readings outside of the expected accuracy range. | 11/19/2019Terminated |
| Z-0713-2020 Class II | MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - Product Usage: pre-calibrated…May result in readings outside of the expected accuracy range. | 11/19/2019Terminated |