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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.

GE Healthcare

Class I - Dangerous

GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).

May 29, 2015 Diagnostic Equipment Nationwide View Details →

ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Siemens Medical Solutions USA

Class I - Dangerous

When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the study.

May 29, 2015 Diagnostic Equipment View Details →

Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures.

Biomet

Class I - Dangerous

Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the incorrect screw is used various failures may occur which may ultimately lead to revision surgery or a delay in surgery.

Jun 3, 2015 Other Medical Devices View Details →

Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.

Roche Diagnostics Operations

Class I - Dangerous

Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.

May 7, 2015 Infusion Pumps Nationwide View Details →

EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and Siemens StreamLAB Automation Solutions.

Siemens Healthcare Diagnostics

Class I - Dangerous

System Limitations and Software Issues related to the following features: Custom reference ranges, User-initiated sample and result actions, Auto-verification and quality control rules, and Sample reports.

Apr 29, 2015 Surgical Instruments Nationwide View Details →

Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a multifunctional microplate reader with injector option. The Infinite F500 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite F500 is intended as a general purpose laboratory instrument for professional use, supporting common microplate conforming to the ANS/SBS standards.

Tecan US

Class I - Dangerous

A firmware bug causes incorrect values to be displayed for specific measured luminescence values.

May 29, 2015 Diagnostic Equipment Nationwide View Details →

JustRight 5mm Reload, JR-REL25-2.0 Reload is packaged in cases of 12., placed in a tray and sealed with a Tyvek lid. Product Usage: The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric, and thoracic surgery for the resection, transection, and creation of anastomosis.

Justright Surgical

Class I - Dangerous

JustRight Surgical is recalling various lots of JustRight 5mm Stapler product because they may deliver incomplete staple formation and incomplete tissue closure.

Jun 11, 2015 Other Medical Devices Nationwide View Details →

HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of HDL-cholesterol concentration in serum and plasma.

Roche Diagnostics Operations

Class I - Dangerous

Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.

May 7, 2015 Infusion Pumps Nationwide View Details →

Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi MODULAR systems, cobas c111, COBAS Integra 800 and 400 plus systems, and cobas c systems.

Roche Diagnostics Operations

Class I - Dangerous

Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.

May 7, 2015 Diagnostic Equipment Nationwide View Details →

Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/Hitachi MODULAR systems, and cobas c systems.

Roche Diagnostics Operations

Class I - Dangerous

Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.

May 7, 2015 Diagnostic Equipment Nationwide View Details →

Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.

Roche Diagnostics Operations

Class I - Dangerous

Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.

May 7, 2015 Infusion Pumps Nationwide View Details →

GE Healthcare Discovery IGS 730. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.

GE Healthcare

Class I - Dangerous

GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).

May 29, 2015 Diagnostic Equipment Nationwide View Details →