Reported Jun 7, 2023 · Ongoing
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. 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 (ELMA)
- included in the below platformsa. Elekta Infinity; b. Versa HD; c. Elekta Synergy
- Lot codes and dates
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 0506019107154305060191071512Elekta Infinity: UDI-DI Number: 05060191071543, 05060191071512 (Serial Numbers: 156073, 152223, 153681) 2 0506019107157405060191071529Versa HD: UDI-DI Number: 05060191071574, 05060191071529 (Serial Numbers: 156941, 156989, 156724, 156998) 3 0506019107155005060191071505Elekta Synergy: UDI-DI Number: 05060191071550, 05060191071505 (Serial Number: 152483) Additional serial numbers distributed OUS: 109331, 109333, 109335, 109336, 109339, 109341, 109342, 151879, 152194, 153038, 153299, 153410, 153970, 156841, 156849, 156966, 156968, 156969, 156970, 156971, 156973, 156977, 156978, 156979, 156980, 156981, 156982, 156983, 156984, 156985, 156986, 156987, 156988, 156990, 156992, 156995, 156996, 156997. - Amount recalled
- 46 units
Where it was sold
Why it was recalled
A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601
This product could cause temporary or reversible health problems — stop using it.
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