Angiodynamics recalls prostate immobilization balloon kits with catalog number ORB-60F due to potential inaccurate radiation therapy readings. Affected units were sold with specific lot numbers and UDI codes.
May result in readings outside of the expected accuracy range.
Angi: OARTRAC prostate immobilization balloon kits (catalog ORB-60F) may give inaccurate radiation therapy readings. This could affect cancer treatment planning if not corrected.
The PSD sensors in these kits may not measure radiation therapy accurately during cancer treatment. This could lead to incorrect dose validation for the patient's targeted area.
Patients undergoing radiation therapy for prostate cancer who use this specific kit may be affected. Those with the catalog number ORB-60F and lot numbers 114290 or 114935 are most at risk.
Check for catalog number ORB-60F on the kit. Lot numbers 114290 or 114935 and UDI code 00851546007066 are associated with this recall.
Look for catalog number ORB-60F, lot numbers 114290 or 114935, and UDI code 00851546007066.
The PSD sensors in these kits may not measure radiation therapy accurately during cancer treatment, potentially affecting dose validation.
Check for catalog number ORB-60F, lot numbers 114290 or 114935, and UDI code 00851546007066. If you have these, contact Angiodynamics for details.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-0709-2020 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-0709-2020 from Angiodynamics. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
