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Tablo Console (Outset Medical) – Heat Damage Risk (2022)

Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.

FDAJan 20, 2022Nationwide• Outset Medical, Inc.

Sight OLO Blood Analysis Device (Sight Diagnostics) – Reference Range Issue (2022)

In instances where custom reference ranges were configured on the device post installation, a possibility to inadvertently apply changes to reference range values was found on software versions 2.59.3 and all earlier versions, which can potentially lead to displaying and printing incorrectly-configured reference range values

FDAJan 20, 2022Nationwide• SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel

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Tablo Console (Outset Medical) – Heat Damage Risk (2022)

Sight OLO Blood Analysis Device (Sight Diagnostics) – Reference Range Issue (2022)

Pediatric Lumbar Puncture Tray (Bard) – Manometer Failure (2022)

Lumbar Puncture Tray Pediatric (Bard) – Manometer Failure (2022)

ACUSON Juniper Ultrasound (Siemens) – Clip Store Malfunction (2022)

SyncVision Systems (Volcano) – Measurement Calculation Error (2022)

LINQ II Cardiac Monitor (Medtronic) – Moisture Ingress Risk (2022)

Opaque Herrick Lacrimal Plugs (Lacrimedics) – Pouch Seal Issue (2022)

Collagen Plugs (Lacrimedics) – Pouch Seal Issue (2022)

Biolox Delta Ceramic Femoral Head (Howmedica) – Size Labeling Error (2022)

CIRRUS HD-OCT Angioplexs (Carl Zeiss) – Scan Clearance Issue (2022)

1688 Camera Control Unit (Stryker) – Image Orientation Defect (2022)

Lexette Topical Foam (Mayne Pharma) – Dispensing Issue (2022)

COVID-19 Antibody Test (Lusys) – Unauthorized Distribution (2022)

Everest MI XT Inner Dilator (Unknown) – Fitting Problem (2022)

LuSys COVID-19 Antigen Test (Lusys) – Unauthorized Distribution (2022)

Everest MI XT Outer Dilator (Unknown) – Fitting Problem (2022)

Luscient COVID-19 Antigen Test (Lusys) – Unauthorized Distribution (2022)

SonialVision G4 X-Ray System (Shimadzu) – Radiation Dose Issue (2022)

Voyager Rollator (Compass Health) – Wheel Spoke Crack (2022)