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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 3121–3140 of 39,430 recalls

Class IIOngoing

Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number 40KWFXPLUS-710CW, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

SED URS LP, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);

Ortho-Clinical Diagnostics, Inc.

Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number 40KWFXPLUS, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number 40KWFX, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);

Ortho-Clinical Diagnostics, Inc.

Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 Superion Indirect Decompression System 12MM, VF Implant 101-9812 00884662000543 Superion Indirect Decompression System 14MM, VF Implant 101-9814 00884662000550 Superion Indirect Decompression System 16MM, VF Implant 101-9816 00884662000567 Superion Indirect Decompression System Kit, VF Instrument 102-9800 00884662000574 The Vertiflex Procedure Instrument Platform, VF Instrument 140-9800 00884662000611 The Superion IDS Kit includes a set of proprietary instruments to deliver the Superion Implant in a minimally invasive manner. Instruments specifically designed for implanting the Superion Implant are sterile, single-use disposable instruments, consisting of a Dilator Assembly, Cannula Assembly, Interspinous Gauge, Inserter, Reamer, and Driver.

Boston Scientific Neuromodulation Corporation

As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device.

June 6, 2025 · DeviceView details →
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