🏥 Medical Devices Class I - Dangerous
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
All Recalls
95,075 total recalls in our database
Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
🏥 Medical Devices Class I - Dangerous
When a user switches on MR1100 Receiver, even though the battery was fully charged, the LED was displayed as orange color due to momentary drop of battery voltage.
Beijing Syntech Laser UL C02 Laser surgical lasers
Beijing Syntech Laser Co.
🏥 Medical Devices Class I - Dangerous
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
SOMATOM Sensation 64 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures.
Beaver-Visitec International
🏥 Medical Devices Class I - Dangerous
Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.
SOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
MultiDiagnost Eleva 708036 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
Philips Medical Systems Nederlands
🏥 Medical Devices Class I - Dangerous
The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user.
Beijing Syntech Laser Diode Laser surgical lasers
Beijing Syntech Laser Co.
🏥 Medical Devices Class I - Dangerous
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
SOMATOM Perspective Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Error introduced into PET images acquired and reconstructed with VJ20A software. Array values are indexed improperly when the norm file is created during QC. During data reconstruction, incorrect values are being applied. This can lead to a gradient in the image. The severity of the error is directly related to the positioning of the PET QC phantom relative to the center of the field of view.
Beijing Syntech Laser UL Station surgical lasers
Beijing Syntech Laser Co.
🏥 Medical Devices Class I - Dangerous
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
Philips Medical Systems Nederlands
🏥 Medical Devices Class I - Dangerous
The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user.
Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
PerkinElmer Life and Analytical Sciences, Wallac, OY
🏥 Medical Devices Class I - Dangerous
Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.
6381 M-1 Cot Fastener, catalog no. 6381000000
Stryker Medical Division of Stryker
🏥 Medical Devices Class I - Dangerous
The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.
Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers
Beijing Syntech Laser Co.
🏥 Medical Devices Class I - Dangerous
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
🏥 Medical Devices Class I - Dangerous
Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.
🏥 Medical Devices Class I - Dangerous
A recent FDA inspection of the firm revealed significant Current Good Manufacturing Practices (cGMP) deficiencies including lack of data to support products conform to final specifications, and lack of expiration dates on the product being recalled.