Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
Summary
The FDA issued a Class II for Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coi by Elekta, Inc.. Reason: There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems..
Details
Source
Device Recall
External ID
Z-1675-2023
Action Date
2023-06-14
Status
Ongoing
Category
device
Product Description
Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
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
Quantity Affected: 18 devices
Reason for Recall
There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.
Distribution
US Nationwide distribution in the states of FL, IA, NJ, NY, OK, PA, TN, WI, MI, LA, KS, NM and TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-06
Company
Atlanta, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 139 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Elekta, Inc. has 24 FDA actions in our database, including 24 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Elekta, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Elekta, Inc. have FDA actions?
Elekta, Inc. has 24 FDA actions in our database, including 24 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1675-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29