Z-0176-2020 Class II Terminated
FDA device recall Z-0176-2020 was initiated by Brainlab AG on September 25, 2019 and is designated Class II. Reason for recall: The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Cranial/ENT/Spine software 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, 2.5.1 (if used in combination wi… The recall status is terminated (terminated March 25, 2024). Affected quantity: 1230 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2019
- Initiation Date
- September 25, 2019
- Termination Date
- March 25, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1230 units
Product Description
Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY 25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE ONLY 25100-12 - PATIENT DATA MANAGER 2.3 INSTALLER 25100-12A - PATIENT DATA MANAGER 2.3.1 INSTALLER 25100-13 - PATIENT DATA MANAGER 2.3 LICENSE 25100-12B - PATIENT DATA MANAGER 2.4.0 INSTALLER 25100-13A - PATIENT DATA MANAGER 2.4 LICENSE 25100-12C - PATIENT DATA MANAGER 2.5.0 INSTALLER 25100-12D - PATIENT DATA MANAGER 2.5.1 INSTALLER 25100-13B - PATIENT DATA MANAGER 2.5 LICENSE used in combination with iPlan CMF/Cranial/ENT/Spine 3.0.5, 3.0.6. Product Usage: Patient Data Manager is intended to load patient data from and export patient data to connected network locations (like file shares and PACS) and removable media. Furthermore, the software is intended to start other applications (like Brainlab planning and navigation applications) and to route applications and connected video sources to displays attached to the system that are running Patient Data Manager. The software is also intended to connect two Brainlab systems to each other via network.
Reason for Recall
The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Cranial/ENT/Spine software 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, 2.5.1 (if used in combination with iPlan CMF/Cranial/ENT/Spine 3.0.5, 3.0.6) that may lead to shifts applied to segmentation objects in iPlan being not reflected when exported into DICOM under specific circumstances.
Distribution Pattern
worldwide
Code Information
Patient Data Manager versions 2.1.1 no GTIN 2.2.0 no GTIN 2.2.1 no GTIN 2.3.0, GTIN 04056481006662 2.3.1, GTIN 04056481132453 2.4.0, GTIN 04056481138615 2.5.0, GTIN 04056481140502 2.5.1, GTIN 04056481140502 versions 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, 2.5.1.