Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will…
Class IIFDA: OngoingPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will…
Class IIFDA: OngoingPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate…
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will…
Class IIFDA: OngoingPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will…
Class IIFDA: OngoingPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed…
Class IFDA: OngoingSiemens Medical Solutions USA, Inc.
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will…
Class IIFDA: OngoingPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will…
Class IIFDA: OngoingPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed…
Class IFDA: OngoingSiemens Medical Solutions USA, Inc.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed…
Class IFDA: OngoingSiemens Medical Solutions USA, Inc.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed…
Class IFDA: OngoingSiemens Medical Solutions USA, Inc.
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are…
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed…
Class IFDA: OngoingSiemens Medical Solutions USA, Inc.
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will…
Class IIFDA: OngoingPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will…
Class IIFDA: OngoingPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be…
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed…
Class IFDA: OngoingSiemens Medical Solutions USA, Inc.
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will…
Class IIFDA: OngoingPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed…
Class IFDA: OngoingSiemens Medical Solutions USA, Inc.
Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range.
Class IIFDA: OngoingSchiller, Ag
About the 2025 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.