Elekta Instrument AB recalls

Elekta Instrument AB has 5 recalls on record with the FDA and USDA, the earliest in 2019 and the latest reported on 13 Nov 2024. 4 are still ongoing. The most frequent reason is foreign material.

Total recalls5since 2019

Last 12 months0reported

Class I240% of total

Ongoing4latest 13 Nov 2024

Recalls per month, last 24 months

click a bar for that month

0Oct '24 1 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 2 40%Class II 3 60%Class III 0 0%

Why elekta instrument ab is recalled

Product types

By year

2024240%
2023120%
2020120%
2019120%

Ongoing elekta instrument ab recalls

4 active

Reported	Class	Recall	Company	Reason	Where
13 Nov 2024Device	CLASS I	Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System recalled	Elekta Instrument AB	Foreign Material	11 states
24 Apr 2024Device	CLASS I	Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System recalled	Elekta Instrument AB	Foreign Material
5 Apr 2023Device	CLASS II	Instructions for Use for the following Leksell Stereotactic recalled	Elekta Instrument AB	Other	Nationwide
29 May 2019Device	CLASS II	Leksell GammaPlan recalled by Elekta Instrument AB	Elekta Instrument AB	Other	Nationwide

All elekta instrument ab recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
13 Nov 2024Device	CLASS I	Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System recalled	Elekta Instrument AB	Foreign Material	11 states
24 Apr 2024Device	CLASS I	Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System recalled	Elekta Instrument AB	Foreign Material
5 Apr 2023Device	CLASS II	Instructions for Use for the following Leksell Stereotactic recalled	Elekta Instrument AB	Other	Nationwide
8 Jul 2020Device	CLASS II	Leksell Vantage Stereotactic System recalled by Elekta Instrument AB	Elekta Instrument AB	Device Malfunction	14 states
29 May 2019Device	CLASS II	Leksell GammaPlan recalled by Elekta Instrument AB	Elekta Instrument AB	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.