There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.
🏨
Other Medical Devices
🏥 Medical Devices • 15,809 recalls
HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
Siemens Healthcare Diagnostics
Class I - Dangerous
Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.
HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.
NxStage Medical
Class I - Dangerous
Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment.
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Onkos Surgical
Class I - Dangerous
Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.
Onkos Surgical
Class I - Dangerous
Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.
ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Plus Initial Drill, Article Number: 103.170;
Straumann USA
Class I - Dangerous
The referred batch was produced without the laser engraving of 7 mm.
Class I - Dangerous
Potential for breach of Tyvek seals.
BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Potential for breach of Tyvek seals.
Class I - Dangerous
Potential for breach of Tyvek seals.
ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.
Onkos Surgical
Class I - Dangerous
Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.
Class I - Dangerous
Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead to an inaccurate measurements.
Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
Philips North America
Class I - Dangerous
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
Cook Incorporated
Class I - Dangerous
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Product Name: Ingenia 3.0T CX; Model Number: 781271;
Philips North America
Class I - Dangerous
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.