Versions 3.0, 3.1, 3.5.1, 3.5.2 and 3.5.3

Radiology, Treatment,

C185

Radiosurgery, Camera

Only Accuray CyberKnife M6 Systems may potentially be affected by these issues.

Stereotactic Systems, Image-Guided, Radiosurgical, Linear Accelerator

two-products from certain lots: BT2000 (SKU 014613) and CPT2000 (SKU 014623)

Manifold Kits

ASP03 REF 14324 Affected lot numbers: all lots manufactured since December 2011, beginning lot 339117.(see attached)

Biological Indicator

All

Disinfectants, destroys microorganisms.

P/N 10033 (STERRAD® NX® Sterilization System)

Sterilization System

p/n GLO2040000

Cleaning products

All

Disinfectants, destroys microorganisms.

P/N GLO2040000 or CRGSE100

Area Decontamination System

ARTG Number (ASDM Part Number, Lots Affected): 133900 (10-1514-075X, Lots manufactured prior to June 2012)

Prosthesis, internal, joint, knee, total - Patella

EF401R

Surgical PENIS CLAMP

TARGON FN TELESCREWS KO820T, KO822T, KO823T, KO824T, KO825T, KO826T, KO828T

The Targon® FN TeleScrews allow a controlled collapse of the fracture along the line of the femoral neck without any backing out of the screws into the soft tissues.

This Safety Notice refers to your DR unit “DX-D 600” (DX-D 600 Automatic System, DX-D 600 Automatic Wall stand Only).

Radiography x-ray imaging system

-Enterprise Imaging for Radiology 8.0.0, 8.0.0 SP1 & 8.0.0 SP2. -Enterprise Imaging for Radiology 8.0.1, 8.0.1 SP1, 8.0.1 SP2, 8.0.1 SP3, 8.0.1 SP4, 8.0.1 SP5 & 8.0.1 SP6. -Enterprise Imaging for Radiology 8.1, 8.1 SP1 & 8.1 SP2.

Radiology

• Enterprise Imaging for Radiology 8.0.0, 8.0.0 SP1 & 8.0.0 SP2. • Enterprise Imaging for Radiology 8.0.1, 8.0.1 SP1, 8.0.1 SP2, 8.0.1 SP3, 8.0.1 SP4, 8.0.1 SP5 & 8.0.1 SP6. • Enterprise Imaging for Radiology 8.1, 8.1 SP1 & 8.1 SP2.

Unified imaging platform

Item Number : 100-13 Lot Number : 130417C6

IVD, Pregnancy Test

(1) 23G TotalPLUS® Pak (2) 23G Combined Procedure Pack, 0.9mm (attached)

Single use consumable items.

Models are tabulated in the attachment

Probes

Multiple lots of the affected device are provided in the attached file

Orthoses, Spine, Cervical

Software version: version 2.20 Serial no.: see attached

Keypoint.NET, Electromyograph

Acid Concentrate for Haemodialysis-HDA08 Lot# 8016040

Haemodialysis, Liquid Acid Concentrate

RAMY 0.5ml, 1ml, 5ml and 10ml insulin syringes

Medical syringes, insulin syringes

Product Description ( CatalogNumber, Lot Number): Soft-Vu® Angiographic Catheter JB(1) Non-Braided 5F x 100cm x 0.035” (10734201, 564325)

Catheters, Cardiac, Angiography

Syramed SP6000 + Volumed VP7000 Volumed ~VP7000 Premium, Volumed ~VP7000 Classic Plus Volumed ~VP7000 Lite Syramed ~SP6000 Premium Syramed ~SP6000 Classic Plus

Syringe pump; Infusion pump