Class II — Elekta, Inc.
| Recalling firm | ELEKTA AB |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values. |
| Product | Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes. |
| Quantity | 498 |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CT, FL, GA, KY, LA, MD, MO, NM, NY, NC, OH, OK, PA, TN, TX, and WA and the countries of Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Iraq, Ireland, Italy, Japan, Jordan… |
| Initiated | 2013-03-28 |
| Classified | 2014-04-02 |
| Terminated | 2017-07-26 |
| Recall number | Z-1322-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Elekta, Inc. (Z-1322-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67574/
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