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Soltive Laser Fibers (Olympus) – Cleaning Instructions (2023)

Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential for the fiber to break during use, which may cause burns, procedure delays, prolonged surgery, and foreign body in patient.

High

FDADec 1, 2023Nationwide• Olympus Corporation of the Americas

P7 32mm Insert (Howmedica) – Material Oxidation Risk (2023)

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Moderate

FDADec 1, 2023Nationwide

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Soltive Laser Fibers (Olympus) – Cleaning Instructions (2023)

P7 32mm Insert (Howmedica) – Material Oxidation Risk (2023)

P7 28mm Insert (Howmedica) – Material Oxidation Risk (2023)

Scorpio-Flex Total Knee Insert (Howmedica) – Material Oxidation Risk (2023)

Primary Rev Tibial Insert (Howmedica) – Material Oxidation Risk (2023)

PS Lipped Tibial Insert (Howmedica) – Material Oxidation Risk (2023)

Omnipod 5 App (Unknown) – Bolus Calculator Error (2023)

Link Patella Glide Guide (Waldemar Link) – Mislabeled Dimensions (2023)

ZOOM LATITUDE Programmer (Boston Scientific) – Diagnostic Date Display (2023)

BrightView XCT (Philips) – Scan Motion Gap (2023)

Tracheostomy Care Tray (Busse) – Saline Lot Recall (2023)

GammaPod Treatment System (Xcision) – Planning Software Error (2023)

bkActiv Ultrasound System (B-K Medical) – Measurement Error (2023)

Tracheostomy Care Set (Busse) – Saline Lot Recall (2023)

Dressing Change Tray (Busse) – Saline Lot Recall (2023)

Spectral CT 7500 (Philips) – Software Functionality (2023)

BrightView Gamma Camera (Philips) – Scan Motion Gap (2023)

BrightView X Camera (Philips) – Scan Motion Gap (2023)

RX Series Copper Assay (Randox) – Carryover Testing (2023)

Ivenix Infusion System (Fresenius) – Pump Valve Interference (2023)