Class I - Dangerous
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001
Roche Diabetes Care
Class I - Dangerous
Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.
Class I - Dangerous
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
Class I - Dangerous
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
Roche Diabetes Care
Class I - Dangerous
Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.
Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
Roche Diabetes Care
Class I - Dangerous
Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.
Class I - Dangerous
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
Class I - Dangerous
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
Class I - Dangerous
Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
OPTI Medical Systems
Class I - Dangerous
The firm identified a precipitation issue which may cause late Ct reactors (a false positive result) with a rate of 5 to 10% for affected vials of RNA Master Mix.
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Cytocell
Class I - Dangerous
May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34
Class I - Dangerous
Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.
Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
Hitachi Healthcare Americas
Class I - Dangerous
The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. Users advised to conduct a preventive inspection of the probe before and after sterilization/disinfection/cleaning and before and after an interoperative procedure.
Units are displaying output readings that differ from the measurements taken using a Gas Analyzer. When the display is reading a target setting of 5%, an external meter is reading between 3% and 12% and the Incubator does not alarm. May result in loss of embryo during storage.
Class I - Dangerous
A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
Class I - Dangerous
Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
Class I - Dangerous
A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in operator misunderstanding and errors during resampling or re-alignment of image data
Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
Class I - Dangerous
A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in operator misunderstanding and errors during resampling or re-alignment of image data
Class I - Dangerous
There is a potential for internal leaks within catheters.
Class I - Dangerous
There is a potential for internal leaks within catheters.