🔍 RecallPedia

Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy

Class I - Dangerous
🏥 Medical Devices Recalled: May 5, 2023 Elekta Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Varex Part Number 95510354H-01 (Varex serial numbers 354-01H_A0010004PC to 354-01H_A0010269PC). a. Elekta Infinity: UDI-DI Number: 05060191071543, 05060191071512 (Serial Numbers: 156073, 152223, 153681); b. Versa HD: UDI-DI Number: 05060191071574, 05060191071529 (Serial Numbers: 156941, 156989, 156724, 156998); c. Elekta Synergy: UDI-DI Number: 05060191071550, 05060191071505 (Serial Number: 152483) Additional serial numbers distributed OUS: 109331, 109333, 109335, 109336, 109339, 109341, 109342, 151879, 152194, 153038, 153299, 153410, 153970, 156841, 156849, 156966, 156968, 156969, 156970, 156971, 156973, 156977, 156978, 156979, 156980, 156981, 156982, 156983, 156984, 156985, 156986, 156987, 156988, 156990, 156992, 156995, 156996, 156997.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Elekta, Inc.
Reason for Recall:
A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy

Product Codes/Lot Numbers:

Varex Part Number 95510354H-01 (Varex serial numbers 354-01H_A0010004PC to 354-01H_A0010269PC). a. Elekta Infinity: UDI-DI Number: 05060191071543, 05060191071512 (Serial Numbers: 156073, 152223, 153681); b. Versa HD: UDI-DI Number: 05060191071574, 05060191071529 (Serial Numbers: 156941, 156989, 156724, 156998); c. Elekta Synergy: UDI-DI Number: 05060191071550, 05060191071505 (Serial Number: 152483) Additional serial numbers distributed OUS: 109331, 109333, 109335, 109336, 109339, 109341, 109342, 151879, 152194, 153038, 153299, 153410, 153970, 156841, 156849, 156966, 156968, 156969, 156970, 156971, 156973, 156977, 156978, 156979, 156980, 156981, 156982, 156983, 156984, 156985, 156986, 156987, 156988, 156990, 156992, 156995, 156996, 156997.

Distribution:

Distributed in: US, AR, IN, LA, OK, TN, VA, WA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1665-2023

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