Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Summary
The FDA issued a Class II for Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy S by Brainlab AG. Reason: Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template.
Details
Source
Device Recall
External ID
Z-1259-2023
Action Date
2023-03-22
Status
Ongoing
Category
device
Product Description
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Lot/Code Info: Versions 1.1.0 and 1.1.1, GTIN: 04056481143978.
Quantity Affected: 56 systems in the U.S.
Reason for Recall
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
Distribution
US Nationwide distribution in the states of AZ, AR, CA, CO, FL, GA. IL, IN, KY, LA, MS, MO, NJ, NY, NC, ND, OK, OR, PA, TN, TX, VA, and WA. There was no government/military distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-14
Company
Munich, N/A
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 134 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Brainlab AG has 32 FDA actions in our database, including 4 recalls and 28 clearances.
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 (Brainlab AG) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Brainlab AG have FDA actions?
Brainlab AG has 32 FDA actions in our database, including 4 recalls and 28 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1259-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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