- Recalling firm
- Elekta, Inc.
- Reason for recall
- Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
- Affected products (lot / model / serial)
- Lot Code: Arc System: UDI:07340048304856 Parts of Arc System: Left Z-Slide: Serial Numbers :UDI: 07340048304818 00001 00625 Right Z-Slide: UDI: 07340048304801/ Serial Numbers: 00001 00675
- Units affected
- 768 (364Left/364Right)
- Distribution pattern
- US: AR AZ CA CO DC FL GA ID IL KS MA MD ME MO MT NC NE NH NJ NM NV NY OH OK PA SC TX UT VA WA WI WV OUS: Algeria Australia Austria Azerbaijan Belgium China Colombia Costa Rica Croatia Czech Republic Egypt Estonia Finland France Germany Greece Hong Kong Hungary India Israel Italy Japan Korea, Republic of Kuwait Lithuania Mexico Morocco Netherlands New Zealand Norway Pakistan Panama Poland Portugal Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey United Kingdom
- Firm location
- Atlanta, GA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2006-2026
- Recall initiated
- March 19, 2026
- FDA classification date
- April 29, 2026
- FDA report date
- May 6, 2026
- FDA event ID
- 98612
- Last updated on HTM Vibe
- July 24, 2026