Recall Z-0273-2019
Medtronic Navigation, Inc.-Littleton · initiated August 30, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, Model Number Bl70000027100 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.
Codes / lots: All Serial Numbers
Reason for recall
Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and logs generation. Software version 3.1.7 will be installed on all 2nd edition imaging systems.
FDA-determined cause: Software design
Action taken
Urgent Medical Device Correction notification letters were sent to customers on 8/30/18. The letter identified the affected letter, problem and actions to be taken. All consignees will received the notification for 3.1.7 software maintenance release. Field service personnel will install the software onto the designed consignee systems.
Details
- Recall number
- Z-0273-2019
- Initiated
- August 30, 2018
- Terminated
- June 18, 2020
- Product code
- OXO – Image-Intensified Fluoroscopic X-Ray System, Mobile
- Quantity
- 596 total
- Distribution
- Worldwide - US Distribution in the states: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and Puerto Rico. The products were distributed to the following foreign countries: Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia…
- Recalling firm
- Medtronic Navigation, Inc.-Littleton, Littleton, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0271-2019 Class II | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number…Software anomalies were reported to affect the following system functionalities: startup and shutdown… | 08/30/2018Terminated |
| Z-0272-2019 Class II | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model…Software anomalies were reported to affect the following system functionalities: startup and shutdown… | 08/30/2018Terminated |
| Z-0274-2019 Class II | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV RWK, Model…Software anomalies were reported to affect the following system functionalities: startup and shutdown… | 08/30/2018Terminated |
| Z-0275-2019 Class II | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number…Software anomalies were reported to affect the following system functionalities: startup and shutdown… | 08/30/2018Terminated |
| Z-0276-2019 Class II | O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK…Software anomalies were reported to affect the following system functionalities: startup and shutdown… | 08/30/2018Terminated |
| Z-0277-2019 Class II | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, Model Number…Software anomalies were reported to affect the following system functionalities: startup and shutdown… | 08/30/2018Terminated |
| Z-0278-2019 Class II | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model…Software anomalies were reported to affect the following system functionalities: startup and shutdown… | 08/30/2018Terminated |
| Z-0279-2019 Class II | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GER, Model…Software anomalies were reported to affect the following system functionalities: startup and shutdown… | 08/30/2018Terminated |
| Z-0280-2019 Class II | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB…Software anomalies were reported to affect the following system functionalities: startup and shutdown… | 08/30/2018Terminated |