CLASS II ONGOING Device recall · Reported 22 Mar 2023 · FDA Enforcement Report

ExacTrac Dynamic recalled by Brainlab AG

Brainlab is recalling ExacTrac Dynamic, distributed nationwide in the US. The recall was initiated on 14 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVersions 1.1.0 and 1.1.1, GTIN: 04056481143978.

Quantity recalled56 systems in the U.S.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1259-2023
FDA event ID: 91664
Recalling firm: Brainlab, Munich, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 14 Feb 2023
FDA classified: 16 Mar 2023
Reported: 22 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

14 Feb 2023	Recall initiated by company
16 Mar 2023	Classified by FDA	+30 days
22 Mar 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.

Where it was distributed

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.

Nationwide Arkansas Arizona California Colorado Florida Georgia Illinois Indiana Kentucky Louisiana Missouri Mississippi North Carolina North Dakota New Jersey New York Oklahoma Oregon Pennsylvania Tennessee

Questions about this recall

Why was it recalled?

Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template

Which lots are affected?

Versions 1.1.0 and 1.1.1, GTIN: 04056481143978.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Brainlab

All 39

Reported	Class	Recall	Company	Reason	Where
26 Mar 2025Device	CLASS II	Origin Data Management recalled by Brainlab AG	Brainlab	Device Malfunction	Nationwide
5 Apr 2023Device	CLASS II	Cirq Arm System recalled by Brainlab AG	Brainlab	Potency & Assay	TX
16 Mar 2022Device	CLASS II	ExacTrac Dynamic recalled by Brainlab AG	Brainlab	Device Malfunction	20 states
16 Jun 2021Device	CLASS II	ExacTrac Dynamic recalled by Brainlab AG	Brainlab	Processing Deviation	Nationwide
17 Mar 2021Device	CLASS II	ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System) recalled	Brainlab	Device Malfunction	8 states

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7 Oct 2026Device	CLASS II	Upgrade to MR recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Positron Emission Tomography and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide