Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF recall — FDA Z-0182-2023
Due to un-commanded movement of mobile x-ray unit.
Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
23,781 detailed records are currently available in this category.
Due to un-commanded movement of mobile x-ray unit.
***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel…
***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel…
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .
Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing.
Batteries could become unstable when not properly maintained and/or subjected to repeated drops, power washing directly into battery contacts or abuse, may result in a fire and/or injury
Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notifications delayed until patient registration is complete; 2) Patches limited to 100 symptomatic and…
***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel…
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant.
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler,…
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection,…
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment…
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler,…
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
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