Stockholm, N/A, Sweden
Elekta Instrument AB recalls
5 recalls recorded since 2018, most recently on 25 September 2024. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)4
Terminated or completed1
Class I (FDA)2
Ongoing Class I Medical devices
- Recall started
- 25 September 2024
- Reason
- Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles.
- Distribution
- US: AZ, TX, FL, CA, NY, GA, VA, NJ, MO, PA, WA,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0227-2025
- Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inne
Ongoing Class I Medical devices
- Recall started
- 15 March 2024
- Reason
- Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles. The sterility of the biopsy needles has not been affected. This issue has been reported from one site.
- Distribution
- US and Australia, Austria, Belgium, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1397-2024
- Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each
Ongoing Class II Medical devices
- Recall started
- 1 March 2023
- Reason
- The incorrect IFU was distributed with the devices.
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, FL, GA, ID, IL, KS, MA, MD, MI, MN, MO, MS, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI, and WV. There was also government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1309-2023
- Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III; (2) Part #A2800-15, Backlund Catheter Insertio
Terminated Class II Medical devices
- Recall started
- 10 June 2020
- Terminated
- 27 August 2024
- Reason
- The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.
- Distribution
- MA, IL, NH, NC, UT, OH, FL, MN, TX, NY, LA, AZ, MT, WV, Austria, Croatia, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Japan, Kuwait, Lithuania, Netherlands, Norway, Portugal, South Africa, Spain, Sweden, Switzerland, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2442-2020
- Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Ongoing Class II Medical devices
- Recall started
- 27 June 2018
- Reason
- The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
- Distribution
- Worldwide Distribution - US Nationwide distribution to GA, MD, NJ, PA, PR, WA. International distribution to Australia, Belgium, France, Germany, Hong Kong, Italy, Japan, Korea, Democratic People's Republic of, Netherlands, Romania, Russian Federation, Spain, Turkey, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1412-2019
- Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.