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IntelliVue Monitors (Philips) – Measurement Series Stopped (2014)

Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped

Class IIModerate

FDAOct 3, 2014Nationwide• Philips Medical Systems, Inc.

FlexiView 8800 Digital Mobile Imaging (GE) – Component Revision (2014)

GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.

Class IIModerate

FDAOct 3, 2014Nationwide

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IntelliVue Monitors (Philips) – Measurement Series Stopped (2014)

FlexiView 8800 Digital Mobile Imaging (GE) – Component Revision (2014)

SideFire Directional Laser Probe (Monteris Medical) – Tip Separation (2014)

OEC 9800 (GE) – Component Revision (2014)

MiniView 6800 (GE) – Component Revision (2014)

Ketorolac Tromethamine Injection (Sagent) – incorrect labeling (2014)

UroView 2800 (GE) – Component Revision (2014)

Ethambutol Hydrochloride Tablets (West-Ward) – Subpotency (2014)

DePuy Synthes Radiolucent Retractor (Synthes) – Adhesive Residue (2014)

Natural Knee II Revision Femoral Stem (Zimmer) – Sterility Breach (2014)

Emtriva Oral Solution (Gilead) – Leaking Container (2014)

Salmon Chowder (Heather's Choice) – Permit Violation (2014)

Transport Rollator (Roscoe Medical) – Caster Separation (2014)

Hydroxyprogesterone Caproate Injection (Avella) – Crystallization (2014)

Operating Room Table (IMRIS) – Missing Pin (2014)

Rancheros (Heather's Choice) – Permit Violation (2014)

Continuum Acetabular System (Zimmer) – Missing Threads (2014)

Hydromorphone Injection (Hospira) – Sterility Concern (2014)

APTUS Ulna Shortening (Medartis) – Bolt Breakage (2014)

Spline Twist Implant (Zimmer Dental) – Incorrect Size (2014)