Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
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.…
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.…
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…
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
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.…
Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.
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.…
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.…
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.
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
May produce erroneously low results from specific well sets.
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
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.…
products may be missing a one-way valve on the fluid patient port.
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.…
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
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…
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.…
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
After continuous operation for more than one and a half days, the image on the large screen monitor may freeze for approximately 15 seconds after which the system will restore itself.
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.…
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