North Carolina recalls

Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable" ergonomics locked until motor replaced; may lead to delay/aborted/alternate procedure

When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.

Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing stored items, delay in the replenishment of ADCs or patient specific medications stored outside of ADCs.

Ophthalmic procedure packs may have incomplete seals affecting sterility.

A certain component of affected devices was not delivered within specification and contained impurities.

A certain component of affected devices was not delivered within specification and contained impurities.

It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Undeclared pecan

Undeclared wheat

Product may be contaminated with Listeria monocytogenes.

Presence of particulate matter: potential presence of metal particulates in the product.

Presence of particulate matter: potential presence of metal particulates in the product.

Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.

Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.

Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.

When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do Not Disturb, and previously set up override permission is deleted, so audible and vibratory notifications not received, which may lead to delayed insulin therapy, hyperglycemia.

Removal of affected lot of screws due to labeling error.

Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.

Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction applied; Manual rotation applied, could result in inaccurate length measurement tool values that could compromise diagnostic accuracy, lead to misdiagnosis or inappropriate follow-up.

GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.