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54 catalysts · 31 device recall · 17 device 510k · 5 approval · 1 device pma
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54 catalysts · 31 device recall · 17 device 510k · 5 approval · 1 device pma
Olympus OER-Mini — Reason: Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance. — Status: Ongoing
IntelliVue Patient Monitor MX450. Product Number: 866062. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing
NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber — Reason: Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction. — Status: Ongoing
IntelliVue MP70. Product Number: M8007A. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing