CLASS II Device recall · Reported 20 Oct 2021 · FDA Enforcement Report
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro recalled
Elekta Solutions AB is recalling Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, distributed in North Carolina, North Dakota. The recall was initiated on 28 Sep 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0115-2022
- FDA event ID
- 88771
- Recalling firm
- Elekta Solutions AB, Stockholm, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Sep 2021
- FDA classified
- 14 Oct 2021
- Reported
- 20 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 28 Sep 2021 | Recall initiated by company | |
| 14 Oct 2021 | Classified by FDA | +16 days |
| 20 Oct 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
Where it was distributed
Distribution was to ND and NC. There was no military/government distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
Elekta Harmony Pro, Serial #441009, UDI (01) 05060191071604; Elekta Infinity, Serial #156645, UDI (01) 05060191071543; and Elekta Versa HD, Serial #156646, #156477, and #156648, UDI (01) 05060191071574
Where was it sold?
Distribution was to ND and NC. There was no military/government distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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