Siemens is releasing a non-medical software application LTA Incomplete Archive Check Tool V1.0. It is intended to eliminate an issue that occurs during syngo.plaza de-archiving from Dicom LTA. It has been defined that the number of de-archived images is less than the count of the archived images for the series. The issues were discovered through Siemens Global Complaint Handling System.
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
Software corrections reactivating the cooperative endoscopy mode.
Observed instability of the device.
The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad Quantification option is calibrated with phantoms that do not have a volume of 6500ml and/or when residual dose needs to be entered.
The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS)
The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad Quantification option is calibrated with phantoms that do not have a volume of 6500ml and/or when residual dose needs to be entered.
Possible break in the connector of the Force Sensor.
Potential failure of the optical distance sensor due to cable disconnection.
Intermittent communication between the host system and the Flex Cardio
North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware
North Star Imaging
Class I - Dangerous
It was discovered a low-level radiation leak that was found on the NSI X-7000 system.
A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected.
Class I - Dangerous
The US FDA has requested the optional energy treatment settings, "medium" and "low" (Software Protocols 02-Medium and 03-Low) be removed from all Ablatherm Integrated Imagining devices in the U.S. until supporting clinical data can be submitted and evaluated by FDA.
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Hologic
Class I - Dangerous
An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.
During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk.
There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000 instrument.
Class I - Dangerous
Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC ampoule will for: " pCO2 give a result close to or just outside of the low end of the control range. (4.92 5.85 kPa or 36.9 46.9 mmHg) " pO2 give a considerable higher result than the expected assigned value of 13.9 -14.3 kPa (104-107 mmHg)
The high control for the kit is recovering low and may be out of range for assigned values.
Class I - Dangerous
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Class I - Dangerous
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Drill Bit Jacobs Chuck 2.0 mm Diameter 85 mm Length, Item Number/EDI 00480508520, Nonsterile. orthopedic surgical instrument.
Zimmer Biomet
Class I - Dangerous
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.