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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71898

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 05, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Brainlab AG

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.

Z-2440-2015
Recall number
Z-2440-2015
Initiated
August 05, 2015
Classification
Class II
Status
Terminated
Recalling firm
Brainlab AG
Quantity
361 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and verification.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software in the Use Environment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and verification.

Code information

Affected are ExacTrac versions 6.0.0 through 6.0.5 (v. 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5). Serial numbers/lot numbers are not applicable for a software version. Software revisions of the ExacTrac software have a specific software version number. Model/catalogue numbers: 70359-01 EXACTRAC 6.0 IR POSITIONING SOFTWARE FOC 20833 EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833A EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833C EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833D EXACTRAC 6.0 IR POSITIONING SOFTWARE 49926 ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49926A ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49927 ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49927A ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49933 ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49933A ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49934 EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49996 ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49996A ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49997 ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED 49997A ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED 49928 ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49928A ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49939 ET SOFTWARE UPDATE 6.0.X to 6.0.4 P&R 49939A ET SOFTWARE UPDATE 6.0.X to 6.0.5 P&R 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49936A ET SOFTWARE UPDATE 6.0.X TO 6.0.4 49936B ET SOFTWARE UPDATE 6.0.X TO 6.0.5 49938 ET SOFTWARE UPDATE 6.0.3TO 6.0.4 49938A ET SOFTWARE UPDATE 6.0.3TO 6.0.5 49973 ET DATA PREP / REVIEW SYSTEM 49973A ET DATA PREP / REVIEW SYSTEM 49973B ET DATA PREP / REVIEW SYSTEM 49998 ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT 49998A ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT

Distribution pattern

Worldwide Distribution - USA including the states of AL, AZ, AK, CA CO, CT, FL, GA, ID, IL IN, KY, LA, MD, MA, MI, MN, NE, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, and WI; and, the countries of Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Netherlands, Panama, Qatar, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.