Reported Oct 20, 2021 · Terminated
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta…
Elekta Solutions Ab
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 SOLUTIONS AB · Box 7593 · Stockholm, N/A · N/A
Is this the product you have?
- Elekta
- Medical Linear Accelerator (EMLA)Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093
- Lot codes and dates
Elekta Harmony ProSerial #441009UDI (01) 05060191071604Elekta InfinitySerial #156645UDI (01) 05060191071543and Elekta Versa HDSerial #156646#156477and #156648UDI (01) 05060191071574
- Amount recalled
- 2 in the U.S.
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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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