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MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N -… recallZ-0713-2020 · Angiodynamics, Inc. · initiated Nov 19, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Angiodynamics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

May result in readings outside of the expected accuracy range.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-0713-2020
Status
Terminated
Initiated by the company
Nov 19, 2019
Recalling firm
Angiodynamics, Inc.
Quantity
48 units
Product code
NZT
FDA submissions
K182395
Distribution
US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA.

Product description

MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - 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.

Code information (models, lots, serial numbers)

Lot Numbers: 106020, 106030, 119400 UDI: 00851546007141

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K182395 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 84382).

Sources and updates

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