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GE Healthcare Centricity Universal Viewer Zero Footprint ... – fire hazard (2024)

Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. The issue occurs when the addendum is created on the same day as the original report but at a different time, and only when launched on the following browsers. " Internet Explorer 10 (IE10) " Internet Explorer 11 (IE11) " Firefox.

Moderate

FDAJul 23, 2024Nationwide• GE Healthcare

Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MI... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)

Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Moderate

FDAJul 23, 2024Nationwide

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GE Healthcare Centricity Universal Viewer Zero Footprint ... – fire hazard (2024)

Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MI... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)

Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope ... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)

Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)

Ciprofloxacin Ophthalmic Solution (FDC) – Defective Container (2024)

VariSoft Infusion Set, Single Use. (Unomedical A/S Osted Aholmvej 1) – specific varisofttm infusion sets wer... (2024)

Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)

Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope ... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)

Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia... (Mindray DS USA, Inc. dba Mindray North America) – v90 electronic vaporizer anesthetic a... (2024)

SlideView VS200 slide viewer, (EVIDENT SCIENTIFIC INC) – a broken fuse inside the laser that w... (2024)

Isoflurane E_Vap.(Safety Filling adapter): used with the ... (Mindray DS USA, Inc. dba Mindray North America) – v90 electronic vaporizer anesthetic a... (2024)

Azelaic Acid Gel (Glenmark) – CGMP Deviation (2024)

Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia ... (Mindray DS USA, Inc. dba Mindray North America) – v90 electronic vaporizer anesthetic a... (2024)

Sevoflurane E_Vap.(Safety Filling adapter) used with the ... (Mindray DS USA, Inc. dba Mindray North America) – v90 electronic vaporizer anesthetic a... (2024)

Everything Roll (Izzio) – Foreign Material Risk (2024)

Aldi Mixed Sourdough Loaf (Izzio) – Foreign Material Risk (2024)

Everything Sourdough (Izzio) – Foreign Material Risk (2024)

Chopped Cilantro with Onion (JFE Franchising) – Listeria risk (2024)

Salsa Medium/Mild (JFE Franchising) – Listeria risk (2024)

Diced Pepper Tri-Blend (JFE Franchising) – Listeria Risk (2024)