Device recall: DMLC IV-ERGO - Beam shaping block for Radiation Therapy.

FDA enforcement event 66048 · Class II · initiated 15 Aug 2013 · status Terminated · terminated 28 Jul 2015

DeviceVoluntary: Firm initiated1 product recordAtlanta, GA

FDA enforcement event 66048 is a device recall by Elekta, Inc. of Atlanta, GA, initiated 15 Aug 2013 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 28 Jul 2015. Initiation: voluntary: firm initiated. Elekta, Inc. has 105 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Elekta, Inc., Atlanta, GA.

Reason for recall

"Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect."

Distribution

"Nationwide distribution: AL, CT, FL, GA, IA, MS, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA and Puerto Rico."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2157-2013	DMLC IV-ERGO - Beam shaping block for Radiation Therapy.	31	Class II	Terminated	11 Sep 2013

Context

90%of 2013 device events are Class II1,236 events that year

1product record in this eventfirm median: 1

105events on this register for the firm

Other enforcement events for Elekta, Inc.

Initiated	Product (first record)	Type	Class	Records
21 May 2026	MOSAIQ Oncology Information System	Device	Class II	1
3 Apr 2026	Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product De	Device	Class II	3
19 Mar 2026	Brand Name: Leksell Vantage Arc System REF: 1053958	Device	Class II	1
18 Feb 2026	Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell G	Device	Class II	1
14 Dec 2025	Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD So	Device	Class II	1
12 Dec 2025	Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Des	Device	Class II	2
10 Dec 2025	MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)	Device	Class II	1
30 Sep 2025	Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product	Device	Class II	1
15 Jan 2025	MOSAIQ Oncology Information System	Device	Class II	1
25 Oct 2023	ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Ac	Device	Class II	6

All 105 events for Elekta, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide distribution: AL, CT, FL, GA, IA, MS, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA and Puerto Rico."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 28 Jul 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.