Elekta, Inc. - Medical Linear Accelerator - Class 2 Recall
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
View ArticlePhilips Medical Systems, Inc. - Philips Healthcare MRx - Class 2 Recall
Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
View ArticleShimadzu Medical Systems - MUX100, MUX100H Xray System - Class 2 Recall
Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatients...
View ArticleLeica Biosystems Imaging, Inc. - ScanScope System - Class 2 Recall
HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast Tissue Manual Read of Digital Slides The ScanScope¿¿ System is an automated digital slide creation, management,...
View ArticleMindray DS USA, Inc. dba Mindray North America - Mindray DS USA, Inc....
Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can also set independent alarm limits for data...
View ArticleClarity Medical Systems Inc - RetCam 3, RetCam Portable and RetCam Shuttle -...
RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.
View ArticleGE Healthcare, LLC - Xray System - Class 2 Recall
GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray imaging systems (X-ray generator installed with Rotor V3 version...
View ArticleSteris Corporation - VERIFY SixCess 270FP Challenge Pack - Class 2 Recall
VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY¿ SixCess 270FP Challenge Pack is used to monitor steam sterilization loads...
View ArticleBoston Scientific Corporation - Boston Scientific RunWay Guide Catheter -...
Boston Scientific, RunWay" Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
View ArticleSmith & Nephew Inc. - RENASYSG Sterile, Gauze Dressing Kit with Soft Port...
Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
View ArticleSmith & Nephew Inc. - RENASYS Soft Port Dressing Kits - Class 2 Recall
Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
View ArticleSmith & Nephew Inc. - RENASYSF XL with Soft Port - Class 2 Recall
Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
View ArticleSmith & Nephew Inc. - RENASYSF Foam Dressing Kit with Soft Port - Class 2...
Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794, 66800795, and 66800796 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy...
View ArticleSmith & Nephew Inc. - RENASYSGauze with Soft Port Kit - Class 2 Recall
Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934, 66800935, and 66800936 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy...
View ArticleSmith & Nephew Inc. - RENASYSAB Abdominal Dressing Kit with Soft Port -...
Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 66800980 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
View ArticleMaquet Cardiovascular Us Sales, Llc - Class 2 Recall
MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given...
View ArticleAccumetrics Inc - VerifyNow IIb/IIIa Test - Class 2 Recall
VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. Product Usage: The VerifyNow System is a turbidimetric based optical detection system which measures...
View ArticleHoriba Instruments, Inc dba Horiba Medical - ABX PENTRA ML - Class 2 Recall
Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software data...
View ArticleGE Healthcare, LLC - GE Healthcare CARESCAPE Monitor B650 and CARESCAPE...
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and...
View ArticleBiosense Webster, Inc. - PENTARAY NAV Catheter - Class 2 Recall
PentaRay Nav High-Density Mapping Catheter, Catalog No. D-1282-01, D-1282-02, D-1282-04, D-1282-05. The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode...
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