Remote Diagnostic Technologies Tempus LS-Manual Defibrillator Model 00-3020 The Tempus recall — FDA Z-0557-2025
Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
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Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or…
There have been cases of failure of the main board due to condensation water drained from the Peltier dehumidifier, leaked out from the tray, resulting in a short circuit. In the serious…
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
The DNA fragments for this specific lot number are too large, resulting in potential background around the cells due to suboptimal hybridization. An absence of signal could also be observed…
Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an…
May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher…
Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an…
Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an…
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric…
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
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