PRECISION 500D SYSTEM

Radiology Devices

2

No

US: Nationwide including DC and Puerto Rico. OUS: Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Egypt, France, Germany, Greece, Honduras, Hungary, Indonesia, Ireland, Israel, Italy, Jamaica, Jordan, Kuwait, Libya, Malaysia, Malta, Mexico, Panama, Portugal, Russia, Saudi Arabia, Saudi Arabia, Slovakia, Spain, Thailand, United Arab Emirates, United Kingdom, Vietnam.

Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems

A list of affected system ID numbers are provided in the attached FSN.

Radiographic/Fluoroscopic Systems

Model Catalog: S0910WB (Lot serial: 00000009908GQ5); Model Catalog: S0910WB (Lot serial: 00000002609GQ6); Model Catalog: S0910WB (Lot serial: 00000009899GQ6); Model Catalog: S0910WB (Lot serial: 00000004108GQ7); Model Catalog: S0910WB (Lot serial: 00000013252GP2); Model Catalog: S0910WB (Lot serial: 00000009902GQ8)

PRECISION 500D RADIOGRAPHIC & FLUOROSCOPIC SYSTEM

Model Catalog: S0910ZC (Lot serial: n/a); Model Catalog: S0912PB (Lot serial: n/a); Model Catalog: S14501BT (Lot serial: n/a); Model Catalog: S13001AX (Lot serial: n/a); Model Catalog: 2258627 (Lot serial: n/a)

PRECISION 500D SYSTEM

Model Catalog: S0915KE (Lot serial: ); Model Catalog: S3918JA (Lot serial: 00000094745HL7); Model Catalog: S3918JA (Lot serial: 00000080557HL2)

Percision 500D System