Device Recall Pinnacle

Part Number: 4513C or 4513-1.  Lot Number: 2014030110

General Hospital and Personal Use Devices

2

No

Worldwide distribution. US Nationwide, Canada, Australia, Netherlands, Switzerland, Japan,

Outer cardboard box labeling: || Pinnacle Cure Sleeve, Curing Light Tip Sleeves. || Kerr Total Care. || Part Number: 4513C or 4513-1 || Single Patient Use || Fits 13mm Tips. Pack of 400. || Metrex Research, Manufacturer. || Inner individual packaging of each sleeve: || Cure Sleeve by Pinnacle || Model 4500

453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451  UPDATED:  453560446051 [A]  459800096361 [Al 453560446061 IA]  459800096541 [A] 453560446091 [A]  459800096741 [A] 453560446101 [A]  459800096921 [A] 453560446111 [A]  459800097111 [A] 453560446131 [A]  459800097291 [A] 453560446141 [A]  459800097471 [A] 453560446161 [A]  459800097651 [B] 453560446181 [A]  459800097831 [B] 453560446201 [A]  459800098171 [B] 459800089221 [A]  459800098351 [A] 459800091451 [A]  459800109261 [A] 459800138101 [BJ 459800189431 [A) 459800220131 [B] 459800239171 [A] 459800233271 [8] 459800233281 [A] 459800233291 [B] 459800233301 [A] 459800233311 [8] 459800233321 [B] 459800233331 [B] 459800233341 [A] 459800233351 [A] 459800233361 [A] 459800234101 [A] 459800234111 [A] 459800234121 [A] 459800318391 [Al 459800405751 [A] 459800417961 [A] 459800249651 [8] 459800249721 [A] 459800249851 [A] 459800249931 [A] 459800250001 [Al 459800250081 [A] 459800250151 [A] 459800250221 [A] 459800250291 [A] 459800250361 [A] 459800250431 [A] 459800250501 [A] 459800250571 [A] 459800338961 [B] 459800340181 [A] 459800340201 [A] 459800341171 [A] 459800341191 [A] 459800341481 [A] 459800341501 [A] 459800345001 [A] 459800345021 [A] 459800345041 [A] 459800345061 [A] 459800345081 [A] 459800345101 [A] 459800454251 [A] 459800455341 [A] 459800493591 [A] 459800494011 [A] 459800554831 [A] 459800554881 [A] 453560435761 453560434881 453560454791 453560461331 453560461341

Radiology Devices

2

No

Worldwide Distribution-US: All states in the US including DC and PR. OUS: Australia, Austria, Bangladesh, Belgium, Brazil, China, Denmark, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands,New Zealand, Oman, Philippines, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, Viet Nam. UPDATED: Canada, Bulgaria, Egypt, Hungary, Jordan, Luxembourg, Poland, Reunion, Romania, Russia, Sauth Arabia, Turkey.

Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451. || UPDATED: || Pinnacle3 Software Version 8.0h, 8.0k, 8.0m, 8.0n.

Software Version 10.0.0 and 14.0.0

Radiology Devices

2

No

US: Nationwide Distribution in the states of FL, OH, and MO.

DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621

Please see Attachment 3

Cardiovascular Devices

2

No

Nationwide Distribution

PINNACLE¿ Introducer Sheath || PINNACLE PRECISION ACCESS SYSTEM¿ Sheath || PINNACLE¿ TIF TIP" Introducer Sheath || PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath

Version 7.0e

Radiology Devices

2

No

The recalled products were shipped to consignees located nationwide the United States and in Australia, Canada, China, and Korea.

Pinnacle3 Radiation Therapy Planning System, Version 7.0e Kit, Model Number 9200-9052A-ENG