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Showing 19901–19920 of 22584 results

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Roche Diagnostics Corp.: Roche brand Accu-Chek Aviva Pediatrics Kit; Catalog numbe...

Incorrect patient blood glucose test results may be reported due to a software problem.

FDANov 9, 2005Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche brand Accu-Chek Aviva Bonus Pack; Catalog number 04...

Incorrect patient blood glucose test results may be reported due to a software problem.

FDANov 9, 2005Nationwide• Roche Diagnostics Corp.

Alsius Corporation: Alsius CoolGard Temperature Regulation System

Alsius has found that fluid spills or ingress may result in an alarm condition. The potential health risk involved in this state can be the discontinuance of therapy.

FDANov 9, 2005Nationwide• Alsius Corporation

Depuy Orthopaedics, Inc.: Depuy brand Acclaim Elbow linked ulnar bearing, sterile; ...

The ulnar bearing may damage the implant's polyethylene sleeve such that revision surgery is necessary.

FDANov 8, 2005Nationwide• Depuy Orthopaedics, Inc.

Stryker Howmedica Osteonics Corp.: Scorpio Total Knee Posteriorly Stabilized Femoral Compone...

Mislabeled boxes -- Scorpio PS Right Femoral Component No Posts contained a Scorpio PS Left Femoral Component with Posts and vice versa.

FDANov 8, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Baxter Healthcare Corp. Rt.: Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M...

Possible shorting of some printed circuit boards could result in a possible interruption of therapy or cause the pump to fail the Power-On Self Test.

FDANov 7, 2005Nationwide• Baxter Healthcare Corp. Rt.

Thomas Medical Products Inc: Bard electrophysiology SSV H. Lee 9.5F split sheath with ...

mislabeled as 9.5F actually contains 10.5F

FDANov 7, 2005CA, CO, IL +12 more• Thomas Medical Products Inc

Merit Medical Systems, Inc: IntelliSystem II Thermal Dot Matrix printer 110 V adapter...

Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard.

FDANov 7, 2005AL, IN, MD +8 more• Merit Medical Systems, Inc

Unknown Manufacturer: Size 6 right Foundation Total Knee System (Catalog #324-0...

The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function.

FDANov 3, 2005AZ, CA, FL +8 more

C.R. Bard, Inc., Urological Division: Bard UroForce Balloon Dilation Catheter with Glissando Co...

There is a potential for the lumen to collapse and prevent passage over a guidewire.

FDANov 3, 2005Nationwide• C.R. Bard, Inc., Urological Division

Ormco Corporation: Damon 3 Bracket Upper Right lateral .022 slot Part Numbe...

Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.

FDANov 3, 2005Nationwide• Ormco Corporation

AGFA Corp.: CR DX-S, DX-S, Computed radiography system (Digitizer)

Corrupted image after system start; Corrupted image after workflow interruption; An erasure unit problem can cause system to stop.

FDANov 3, 2005MS, OR, DC• AGFA Corp.

Unknown Manufacturer: Size 8 right 3DKnee Non-porous Baseplates (Catalog #333-0...

The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function.

FDANov 3, 2005AZ, CA, FL +8 more

Ciba Vision Corporation: AQuify Drops, Long Lasting Comfort Drops * Relieves Dryne...

Lack of assurance of sterility at the time of manufacture.

FDANov 2, 2005Nationwide• Ciba Vision Corporation

Hospira Inc: Hospira LifeCare PCA3 Infusion System Software, versions ...

Incorrect values for dosage, dose limit, concentration or rate of delivery may display on screen.

FDANov 2, 2005Nationwide• Hospira Inc

Abbott Spine: TraXis Vue Spinal Implant System, Part #2601-090921

Implants were manufactured without radiographic markers.

FDANov 2, 2005Nationwide• Abbott Spine

Tung Keng Enterprise Co., Ltd. No.1, Lane 160, Section 2, Tan-Fu Road Tai-Tzu Hsiang, Taichung County Taiwan: The product is a mobile 3-wheeled electric scooter, model...

The throttle spring, located in the hand throttle assembly, can fracture, resulting in the scooter not stopping when the user releases the throttle.

FDANov 1, 2005CA, IN, OH +1 more• Tung Keng Enterprise Co., Ltd. No.1, Lane 160, Section 2, Tan-Fu Road Tai-Tzu Hsiang, Taichung County Taiwan

Orthohelix Surgical Designs Inc: MaxLock Screwdriver, part MXS-056. This is a surgical in...

Screwdriver pilot taper tip can break during surgery.

FDANov 1, 2005CO, FL, GA +5 more• Orthohelix Surgical Designs Inc

Synovis Surgical Inovation Div. of: Peri-Strips Dry with Veritas Collagen Matrix Circular Sta...

The Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement devices involved have a small chance that a seal on the outer pouch may not be completely reliable.

FDANov 1, 2005Nationwide• Synovis Surgical Inovation Div. of

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1; 100V -120V, 15 A (cir...

The power manager subsystem may not initialize properly during start-up, which will cause the battery status monitoring and battery switching operations to not be fully functional.

FDANov 1, 2005Nationwide• Terumo Cardiovascular Systems Corp

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