Class II U.S. Food and Drug Administration

Elekta, Inc. Brand Name: Leksell Gamma Knife recall: Due to adapter not being properly aligned or locked in place

Recall published 7 months ago

Due to adapter not being properly aligned or locked in place.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Due to adapter not being properly aligned or locked in place.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1581-2026
Published
March 25, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Elekta, Inc.
Product type
Medical devices
Units affected
352
Distribution
Nationwide
Sold at
Target
Made in
United States
Lot / code info
Lot Code: 07340048303019 (Perfexion) Product and Serial Numbers: LGK Perfexion/11868-004/6002 LGK Perfexion/12214-003/6007 LGK Perfexion/10567-026/6011 LGK Perfexion/10567-024/6014 LGK Perfexion/12451-001/6019 LGK Perfexion/10064-008/6021 LGK Perfexion/18630-001/6031 LGK Perfexion/11813-003/6034 LGK Perfexion/11007-005/6035 LGK Perfexion/10908-003/6045 LGK Perfexion/13337-LGK001/6052 LGK Perfexion/10762-005/6057 LGK Perfexion/11550-001/6065 LGK Perfexion/14878-003/6067 LGK Perfexion/11792-005/6077 LGK Perfexion/10356-007/6079 LGK Perfexion/10924-001/6089 LGK Perfexion/15045-LGK001/6091 LGK Perfexion/11848-003/6095 LGK Perfexion/12236-006/6097 LGK Perfexion/13558-001/6099 LGK Perfexion/20364-001/6103 LGK Perfexion/10848-LGK001/6108 LGK Perfexion/11390-LGK001/6109 LGK Perfexion/30002718-001/6113 LGK Perfexion/11433-LGK001/6116 LGK Perfexion/10643-005/6117 LGK Perfexion/11990-LGK001/6118 LGK Perfexion/12620-002/6120 LGK Perfexion/17322-001/6121 LGK Perfexion/105528-001/6122 LGK Perfexion/11999-001/6126 LGK Perfexion/10917-004/6128 LGK Perfexion/17357-001/6130 LGK Perfexion/10394-LGK01/6144 LGK Perfexion/30002934-ENS/6160 LGK Perfexion/10583-LGK002/6161 LGK Perfexion/16867-001/6166 LGK Perfexion/10929-LGK002/6175 LGK Perfexion/10424-001/6182 LGK Perfexion/17539-001/6185 LGK Perfexion/11377-003/6186 LGK Perfexion/16647-001/6187 LGK Perfexion/11733-001/6192 LGK Perfexion/10960-005/6193 LGK Perfexion/21061-001/6195 LGK Perfexion/11439-002/6196 LGK Perfexion/30000655-001/6199 LGK Perfexion/11731-005/6200 LGK Perfexion/11149-LGK002/6206 LGK Perfexion/11077-007/6207 LGK Perfexion/30001910-001/6208 LGK Perfexion/13514-001/6211 LGK Perfexion/10979-002/6213 LGK Perfexion/10208-003/6215 LGK Perfexion/11127-009/6219 LGK Perfexion/30000732-001/6223 LGK Perfexion/30001270-001/6225 LGK Perfexion/11420-001/6228 LGK Perfexion/30001527-001/6231 LGK Perfexion/10879-LGK002/6234 LGK Perfexion/10698-001/6237 LGK Perfexion/10711-002/6243 LGK Perfexion/10148-LGK002/6245 LGK Perfexion/12748-LGK001/6248 LGK Perfexion/11536-LGK002/6251 LGK Perfexion/10567-044/6253 LGK Perfexion/10425-LGK002/6254 LGK Perfexion/11434-LGK002/6255 LGK Perfexion/13031-LGK/6256 LGK Perfexion/11006-LGK002/6259 LGK Perfexion/30000722-003/6261 LGK Perfexion/10537-LGK002/6264 LGK Perfexion/30001107-002/6265 LGK Perfexion/10630-002/6266 LGK Perfexion/11524-002/8001 LGK Perfexion/12643-001/8010 LGK Perfexion/30003042-001/8011 LGK Perfexion/11695-LGK002/8015 LGK Perfexion/11322-002/8028 LGK Perfexion/10700-LGK002/8044 LGK Perfexion/12957-003/8053 LGK Perfexion/11787-003/8059 LGK Perfexion/30000346-001/8065 LGK Perfexion/30004796-RS001/8078 LGK Perfexion/11131-LGK002/8098 LGK Perfexion/13252-LGK001/8106 LGK Perfexion/30000269-LGK001/8109 LGK Perfexion/15490-003/8124 LGK Perfexion/30002079-LGK001/8180 07340048305587 (Icon) Product and Serial Numbers: LGK Icon/30004749-LGK001/8099 LGK Icon/14750-LGK001/8083 LGK Icon/12579-007/6250 LGK Icon/18850-500/8005 LGK Icon/11920-C5210/6088 LGK Icon/30004694-003/8064 LGK Icon/30000718-002/6246 LGK Icon/30004889-LGK001/8087 LGK Icon/14765-003/8027 LGK Icon/12473-003/6005 LGK Icon/12274-014/6209 LGK Icon/10611-001/6081 LGK Icon/11720-002/6143 LGK Icon/12846-004/6064 LGK Icon/12242-003/8085 LGK Icon/30005412-002/8114 LGK Icon/12178-002/8002 LGK Icon/12685-007/8105 LGK Icon/10545-009/8072 LGK Icon/12926-001/6212 LGK Icon/14915-003/6236 LGK Icon/30004236-003/8117 LGK Icon/30002968-004/8030 LGK Icon/12668-008/8178 LGK Icon/14983-500/6076 LGK Icon/11916-001/8056 LGK Icon/11083-HOM001/6070 LGK Icon/15554-001/8103 LGK Icon/15661-502/8121 LGK Icon/10247-002/6136 LGK Icon/30000736-003/8108 LGK Icon/30005910-001/8127 LGK Icon/11676-003/8040 LGK Icon/11976-502/8035 LGK Icon/11868-008/6131 LGK Icon/12947-003/8122 LGK Icon/11290-ENS1/6174 LGK Icon/18464-003/8066 LGK Icon/10795-K08002/6063 LGK Icon/30004024-RS01/6201 LGK Icon/11291-001/6018 LGK Icon/10326-003/6105 LGK Icon/21121-002/8067 LGK Icon/10783-003/8077 LGK Icon/30004796-RS001/8078 LGK Icon/30006128-500/81…
UPC codes
07340048303019, 07340048305587

Products covered by this recall

Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.

Check your product

The notice names 10 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 07340048303019
  • 07340048305587

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 07340048303019

Serial number

On the rating plate, often next to the date of manufacture.

  • LGK Perfexion
  • 11868-004
  • 6002 LGK Perfexio
  • LGK Icon
  • 30004749-LGK001
  • 8099 LGK Icon
  • 14

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Elekta, Inc. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Elekta, Inc. — 400 Perimeter Center Ter NE Ste 50, Atlanta, GA, 30346-1227

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Elekta, Inc. medical devices recalled?

Due to adapter not being properly aligned or locked in place. Due to adapter not being properly aligned or locked in place.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 07340048303019, 07340048305587; lot code 07340048303019. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide, including at Target.

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