Recall Z-0273-2014 ยท EBW Controller, Foot, Handpiece And Cord
Nobel Biocare Usa Llc
Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.
| Date | Nov 13, 2013 (initiated Oct 24, 2013) |
| Status | Terminated |
| Reason | The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when used with the OseeoCare Pro iPad application software release 1.2.0.7. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Bien Air Dental send and Urgent Field Safety Notice dated October 24, 2013, to all affected customers. The letter notified customers of the recall, description of the problem, description of the product (OsseoCare Pro iPad app software release 1.2.0.7), action to be taken by user, an alternative solution, and contact details. The letter was also accompanied by an acknowlegement form. Customers with questions were instructed to call 1-800-433-2436. For questions regarding this recall call 714-282-4800. |
| Quantity | 1082 (391 US) |
| Distribution | Worldwide Distribution - USA (nationwide) United States and Internationally to Austria, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Mexico, Netherlands, Norway, Philippines, Pola |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092214 | CHIROPRO L SYSTEM Bien-Air Dental, SA, Dec 15, 2009 |