Medical equipment, implants, and diagnostic devices
Siemens Healthcare Diagnostics
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
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 Co.
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".
Siemens Medical Solutions USA
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
Beaver-Visitec International
Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.
Siemens Medical Solutions USA
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
Siemens Healthcare Diagnostics
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
Philips Medical Systems Nederlands
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 Co.
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".
Siemens Medical Solutions USA
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
Siemens Medical Solutions USA
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 Co.
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".
Philips Medical Systems Nederlands
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.
PerkinElmer Life and Analytical Sciences, Wallac, OY
Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.
Stryker Medical Division of Stryker
The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.
Siemens Healthcare Diagnostics
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 Co.
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".
Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.
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.
Siemens Medical Solutions USA
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