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Showing 5601–5620 of 8393 results

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Atellica IM Folate 700 Test Kit (Siemens) – Calibration Bias (2023)

Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

FDAJan 9, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

ADVIA Centaur Folate 500 Test Kit (Siemens) – Calibration Bias (2023)

Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

FDAJan 9, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

Respiratory Care Breathing Circuit (S & Mohr) – Expiration Label Error (2023)

Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027"

Moderate

FDAJan 5, 2023Nationwide• S & MOHR AMERICA, S.A. DE C.V. Circuito De La Industria Poniente Lote 10 C Estado De Mexico Mexico

Smart Correction Dual Joint Struts (Wishbone) – Adjustment Pin Issue (2023)

Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint Express Struts due to the collar release pin backing out. This may lead to a delay in correction.

FDAJan 4, 2023Nationwide• Wishbone Medical, Inc.

Broviac Catheter Repair Kit (Bard) – Adhesive Hardening (2023)

Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).

FDAJan 4, 2023Nationwide• Bard Peripheral Vascular Inc

Digital VIPR Oxygen Gauge (Western/Scott Fetzer) – Pressure Malfunction (2023)

Gauge malfunction: Digital gauge displays an incorrect tank pressure - displays pressure higher than actual tank pressure. This may lead to tank running out of oxygen during use without audible alarms, potentially leading to an out of oxygen event and no flow.

FDAJan 3, 2023Nationwide• Western/Scott Fetzer Company

FluidShield Procedure Mask (Owens & Minor) – Incorrect Box Labeling (2023)

Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops.

FDAJan 3, 2023IL, NY, NC +2 more• Owens & Minor Distribution, Inc.

Vanguard Knee System (Biomet) – Incorrect Component Labeling (2022)

Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).

FDADec 29, 2022FL, IN, MD +3 more• Biomet, Inc.

MyDay & Reveal Toric Contacts (CooperVision) – Incorrect Power (2022)

Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.

FDADec 27, 2022CA, FL, IA +6 more• CooperVision, Inc.

Medline Maximum Barrier Pack (Medline) – Improper Sterilization (2022)

The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.

FDADec 27, 2022Nationwide• MEDLINE INDUSTRIES, LP Northfield

Medline Sterile Hand Pack (Medline) – Improper Sterilization (2022)

The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.

FDADec 27, 2022Nationwide• MEDLINE INDUSTRIES, LP Northfield

Medline Oncology Port Access Tray (Medline) – Improper Sterilization (2022)

The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.

FDADec 27, 2022Nationwide• MEDLINE INDUSTRIES, LP Northfield

LinkSymphoKnee Augment (Waldemar Link) – Screw Orientation Error (2022)

Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).

FDADec 23, 2022Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Precision Delivery Set (Quest Medical) – Tubing Detachment Risk (2022)

Delivery Sets may have tubing that could become detached that could result in patient infection.

FDADec 23, 2022Nationwide• Quest Medical, Inc.

Centurion VAD Drive (Medline) – Expired Component (2022)

The kit contained an expired component.

FDADec 23, 2022Nationwide• MEDLINE INDUSTRIES, LP Northfield

Incisive CT Scanner (Philips) – Software Misdiagnosis Risk (2022)

Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occur on perfusion images, 2. Orientation label reversed in 2D images, 3. Auto voice does not work during the cardiac scan, 4. Auto voice and operators voice are too quiet, patient cant hear, 5. Not all of the images are reconstructed in some cases, 6. No image displayed on the console monitor after enabling CCT Single Scan, 7. Ring artifact appears in 32x0.625 collimation of bone scan when soft tissue view is selected, 8. A design defect where the error couch motion signal of couch firmware causes couch to identify current position as target position in next protocol, and 9. calcium scoring study split into separate series after loading to ISP.

FDADec 23, 2022Nationwide• Philips Healthcare (Suzhou) Co., Ltd. Suzhou Industrial Park No.

myNeedle Guide Software (Siemens) – Orientation Label Error (2022)

In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels head , center, and feet in the axial thick slice segments are erroneously swapped

FDADec 22, 2022Nationwide• Siemens Medical Solutions USA, Inc

HydroMID Catheter Kit (Access Vascular) – Mislabeling Issue (2022)

Product Mislabeled on the outer bag and inner kit Tyvek header bag

FDADec 22, 2022Nationwide• Access Vascular, Inc

RipCord Syndesmosis Button (TriMed) – Tension Failure Risk (2022)

Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.

FDADec 22, 2022Nationwide• TriMed Inc.

Getinge Flow-c Anesthesia System (Getinge) – Ventilation Risk (2022)

Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.

FDADec 22, 2022Nationwide• Getinge Usa Sales Inc

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