CLASS II Device recall · Reported 16 Jun 2021 · 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 May 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVersion 1.02, GTIN 04056481142315

Quantity recalled22 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-1846-2021
FDA event ID: 87984
Recalling firm: Brainlab, Munich, N/A
Classification: Class II
Status: Terminated
Recall initiated: 14 May 2021
FDA classified: 10 Jun 2021
Reported: 16 Jun 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Processing Deviation
Device type: Patient Monitors

Timeline

14 May 2021	Recall initiated by company
10 Jun 2021	Classified by FDA	+27 days
16 Jun 2021	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

Display of potential patient movement might be delayed to the user for high dose treatments.

The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.

Product as listed by the FDA

ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

Where it was distributed

US Nationwide distribution in the states of AZ, AR, CA, FL, IN, NJ, NY, NC, OR, PA, and TX. There was no government/military distribution.

Nationwide Arkansas Arizona California Florida Indiana North Carolina New Jersey New York Oregon Pennsylvania Texas

Questions about this recall

Why was it recalled?

Display of potential patient movement might be delayed to the user for high dose treatments.

Which lots are affected?

Version 1.02, GTIN 04056481142315

Where was it sold?

US Nationwide distribution in the states of AZ, AR, CA, FL, IN, NJ, NY, NC, OR, PA, and TX. 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
22 Mar 2023Device	CLASS II	ExacTrac Dynamic recalled by Brainlab AG	Brainlab	Device Malfunction	Nationwide
16 Mar 2022Device	CLASS II	ExacTrac Dynamic recalled by Brainlab AG	Brainlab	Device Malfunction	20 states
17 Mar 2021Device	CLASS II	ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System) recalled	Brainlab	Device Malfunction	8 states

Other Patient Monitors recalls

All 1,022

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS III	Passport Series Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	T1 Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	cPM Series Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	BeneVision Series Telemetry Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	Panorama and Telemetry Monitoring System recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide