Reported Oct 20, 2021 · Terminated
Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta…
Elekta, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elekta, Inc. · 400 Perimeter Center Ter NE Ste 50 · Atlanta, GA · 30346-1227
Is this the product you have?
- Elekta Medical Linear Accelerator (EMLA)
- configured as followsa. Elekta Precise Digital Accelerator; b. Elekta Harmony; c. Elekta Synergy; d. Elekta Infinity; e. Versa HD
- Lot codes and dates
5 of 5 products
Products covered by this recall # Barcodes Product as published 1 5060191071017Elekta Precise Digital Accelerator - UDI GTIN Number: 5060191071017, Model Numbers: XRT 0601 (NFB), XRT 0611 (FB), All Serial Numbers 2 05060191071581Elekta Harmony - UDI GTIN Number: 05060191071581, Model Numbers: XRT 2201 (NFB), All Serial Numbers 3 05060191071550Elekta Synergy - UDI GTIN Number: 05060191071550, Model Numbers: XRT 0621 (NFB), XRT 0631 (FB), All Serial Numbers 4 0506019107154305060191071512Elekta Infinity - UDI GTIN Number: 05060191071543, 05060191071512, Model Numbers: XRT 0511 (NFB & MLCi2), XRT 0521 (FB & MLCi2), XRT 0531 (NFB & Agility), XRT 0541 (FB & Agility), All Serial Numbers 5 0506019107157405060191071529Versa HD - UDI GTIN Number: 05060191071574, 05060191071529, Model Numbers: XRT 2121 (NFB), XRT 2131 (FB), All Serial Numbers - Amount recalled
- 4,405 units
Where it was sold
Why it was recalled
There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.
This product could cause temporary or reversible health problems — stop using it.
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