Elekta recalls Agility with Integrity R3.2 devices due to potential positional errors when automatic table movement occurs. Affected units have product code 90I--YE and no serial numbers.
Potential for positional errors following automatic table movement (ATM).
Elekta is recalling its Agility with Integrity R3.2 surgical table models because they may cause positional errors during automatic table movement. This could lead to incorrect positioning of patients during procedures, potentially affecting treatment outcomes.
The automatic table movement feature may cause the table to shift unexpectedly, leading to incorrect patient positioning during procedures. This could result in treatment errors or complications if not properly monitored.
Surgical staff and patients using Elekta Agility with Integrity R3.2 tables with product code 90I--YE. Those in medical settings where these tables are used are most at risk.
Check for product code 90I--YE on the device label. These models do not have serial numbers and were sold as part of the Agility with Integrity R3.2 line.
Look for product code 90I--YE on the device label to confirm if it's affected.
The recall is due to potential positional errors following automatic table movement, which could affect patient positioning during procedures.
Affected tables have product code 90I--YE and no serial numbers.
The recall record does not specify a remedy, so contact Elekta for further instructions.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-0723-2018 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-0723-2018 from Elekta. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.