Class I - Dangerous
Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm
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Infusion Pumps
🏥 Medical Devices • 4,262 recalls
Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it should be "R(Right)".
Syngo Dynamics; Kinetdx Picture Archiving and Communications System
Siemens Medical Solutions USA
Class I - Dangerous
Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. If the template design has measurements inside a carry forward-configured report section, this will result in carrying forward the entire section of the report including data from previous studies. This may result in the physician making analysis based on the old measurements.
Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it should be "R(Right)".
Incorrect Power Supply in the package, rendering the device inoperable.
Class I - Dangerous
The label on the Tyvek bag is missing. This is used by customers to identify material code, lot number, and expiration date once the product is removed from the shipper box.
Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar is contaminated with Listeria Monocytogenes. The device is a non-sterile prepared plated media.
CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information
Medtronic MiniMed
Class I - Dangerous
Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink iPro reports were created using the Pacific Standard Time zone as the time reference, although the patients and their sensor data were subject to the Central Standard Time zone. The CareLink iPro2 Professional CGM (continuous glucose monitor) data uploading error that resulted in an inaccurate time zone being applied to 19 CareLink iPro reports.
Robotic Arm Interactive Orthopedic System (RIO)
Mako Surgical
Class I - Dangerous
Revision of the field manual
Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
Maquet Cardiovascular Us Sales
Class I - Dangerous
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
Class I - Dangerous
The Spetzler Claw Tip was packaged with the incorrect Tip Sleeve Assembly. The Tip Sleeve Assembly included in the packaging is the incorrect size. Risk to Health: If the Tip Sleeve Assembly does not fit the Spetzler Claw" Tip, a surgical delay may occur while an alternate Tip Sleeve Assembly is retrieved.
Class I - Dangerous
Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
Class I - Dangerous
ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml.
Class I - Dangerous
Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
Class I - Dangerous
ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml.
Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.
Natus Medical Incorporated
Class I - Dangerous
NatalCare LX Incubators were manufactured using a defective oval port hinge assembly with the result that the screws holding the port in place can become loose and possibly result in the port detaching from the incubator.
Class I - Dangerous
ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml.