Device recall: ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to…
Class II FDA enforcement event 87984. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Display of potential patient movement might be delayed to the user for high dose treatments.
Class II, in the words of FDA
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
Brainlab AG started this device recall on 14 May 2021. The firm address in the FDA record is in Munich. FDA put the recall in Class II. FDA event 87984 has 1 product record. The first FDA enforcement report date is 16 Jun 2021. The record gives the status Terminated, with the termination date 20 Mar 2023.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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.
Recalling firm
Brainlab AG, Munich, N/A, Germany.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1846-2021 | 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… | 22 systems in the U.S. | Class II | Terminated | 16 Jun 2021 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2021
- 900
- Share of these events in Class II
- 89%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 36
Other events of the firm
Official channels
- FDA enforcement report Z-1846-2021The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 87984. https://recallregister.com/fda/ii/87984/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
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 quantity of product is in FDA event 87984?
- The FDA record gives this quantity:
22 systems in the U.S.
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2021 have the same class?
- 89% of the 900 device events that started in 2021 are in Class II.