Recalls / —

—#199492

Product

Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.

FDA product code

IYE — Accelerator, Linear, Medical

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K212114

Affected lot / code info

UDI GTIN 05060191071598, serial numbers: 14117-007/600034, 10632-010/600036, 10817-011/600010, 10905-008/600037, 11198-010/600047, 11198-011/600048, 11830-010/600064, 11888-004/600072, 12108-007/600019, 13371-002/600021, 13553-006/600003, 30003193-003/600074, 13120-017/600073, 11328-019/600059, 14232-001/600095, 12269-004/600100, 11008-003/600104, 13212-007/600106

Why it was recalled

There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.

Root cause (FDA determination)

Process design

Action the firm took

The recalling firm issued the Field Safety Notice dated March 2023 via email on 4/6/2023 describing the problem, the clinical impact, and the recommended user action, which is that no actions are required to be taken by the user. The Unity system is safe for clinical use without restriction. The consignee is informed the letter is to notify them there will be action taken on the Elekta Unity system to further reduce the potential risk of overheating within the MR Gradient Coil which could lead to system downtime. The letter is to be posted in a place accessible to all users and appropriate personnel are to be advised on the content of the letter. The letter contains Elekta Corrective Actions, which says the update will be provided via Elekta's Field Change Order process once available and that their local Elekta service representative will contact the consignee to arrange for this activity to be completed. An acknowledgement Form was enclosed to be returned to Elekta immediately upon receipt but no later than within 30 days. The device serial number and location or site of the device is to be reported and the consignee is to sign it to acknowledge they have read and understand the notice and accept the implementation of any given recommendation. UPDATED 12-JUN-23 An updated Important Field Safety Notification was released to customers by email in which supersedes the previous Notice under ref: 200-01-801-012 released on 06-APR-23. The new FSN includes additional information under Recommended User Action.

Recalling firm

Firm

Elekta, Inc.

Address

400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern

US Nationwide distribution in the states of FL, IA, NJ, NY, OK, PA, TN, WI, MI, LA, KS, NM and TX.

Timeline

Recall initiated

2023-04-06

Posted by FDA

2023-06-02

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #199492. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.