BEUDAMED
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    ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRGs) as follows: Part Numbers: 1. 799-EGL2-02 2. 799-EGL2-02-01 3. 799-EGL2-02-04 4. 799-EGL2-02-05 5. 799-EGL2-02-08 6. 799-EGL2-02-10 7. 799-EGL2-02-11 8. 799-EGL2-02-15 9. 799-EGL2-02-16 10. 799-EMBP-05-01 11. 799-EMBP-05-02 12. 799-EMBP-05-08 13. 799-EMBP-05-10 14. 799-EMBP-05-11 15. 799-EMBP-05-12 16. 799-EMBP-05-12-68 17. 799-EMBP-05-16 18. 799-EMBP-05-23 19. 799-EMVP-05 20. 799-EMVP-05-01 21. 799-EMVP-05-05 22. 799-EMVP-05-10 23. 799-EMVP-05-15 24. 799-EMVP-05-16 Manual Part Numbers 906-0731-01; 9650-002365-01 (US); 906-0731-01-05 (CAN); 906-0731-01-10; 9650-0002363-01; 906-0731-01 (Commercial); 906-0731-03 (Military); 9650-0002363-01; 9650-0002363-05; 906-0731-01; 906-0731-01-05 (CAN); 906-0731-01-04; 906-0731-01-05; 906-0731-01-08; 906-0731-01-10; 906-0731-01-11; 906-0731-01-15; 906-0731-01-16; 9650-0002363-01; 9650-0002363-02; 9650-0002363-08; 9650-0002363-10; 9650-0002363-11; 9650-0002363-12; 9650-0002363-16; 9650-0002363-23; 906-0731-01 (Commercial); 906-0731-03 (Military); 9650-0002363-01; 9650-0002363-05; 9650-0002363-10; 9650-0002363-15; 9650-0002363-16 Quick Reference Guide (QRG) Part Numbers: 907-0731-04; 9652-000499-01; 9652-000511-01; 907-0731-04; 9652-000511-01; 907-0731-04; 9652-000499-01; 9652-000499-04; 9652-000499-08; 9652-000499-10; 9652-000499-11; 907-0731-04; 9652-000499-16; 9652-000511-01; 9652-000511-02; 9652-000511-08; 9652-000511-10; 9652-000511-11; 9652-000511-12; 9652-000511-16; 9652-000511-23; 907-0731-04; 9652-000511-01; 9652-000511-05; 9652-000511-10; 9652-000511-15; 9652-000511-16

    FDA Enforcement
    Class I ·Ongoing·ZOLL Medical Corporation·June 26, 2024

    Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 degrees, Part #325-07102510, nonsterile; (3) Calibrate CCX-O, 7 x 10 x 25mm 15 degrees, Part #325-07102515, nonsterile; (4) Calibrate CCX-O, 7 X 10 X 30mm 5 degrees, Part #325-07103005, nonsterile; (5) Calibrate CCX-O, 7 x 10 x 30mm 10 degrees, Part #325-07103010, nonsterile; (6) Calibrate CCX-O, 7 x 10 x 30mm 15 degrees, Part #325-07103015, nonsterile; (7) Calibrate CCX-O, 7 x 10 x 35mm 10 degrees, Part #325-07103510, nonsterile; (8) Calibrate CCX-O, 7 x 10 x 35mm 15 degrees, Part #325-07103515, nonsterile; (9) Calibrate CCX-O, 9 x 10 x 25mm 5 degrees, Part #325-09102505, nonsterile; (10) Calibrate CCX-O, 9 x 10 x 25mm 10 degrees, Part #325-09102510, nonsterile; (11) Calibrate CCX-O, 9 x 10 x 30mm 5 degrees, Part #325-09103005, nonsterile; (12) Calibrate CCX-O, 9 x 10 x 30mm 10 degrees, Part #325-09103010, nonsterile; (13) Calibrate CCX-O, 11 x 10 x 30mm 10 degrees, Part #325-11103010, nonsterile; (14) Calibrate CCX-S, 7 x 10 x 22mm 5 degrees, Part #326-07102205, nonsterile; (15) Calibrate CCX-S, 7 x 10 x 22mm 10 degrees, Part #326-07102210, nonsterile; (16) Calibrate CCX-S, 7 x 10 x 22mm 15 degrees, Part #326-07102215, nonsterile; (17) Calibrate CCX-S, 7 x 10 x 26mm 5 degrees, Part #326-07102605, nonsterile; (18) Calibrate CCX-S, 7 x 10 x 26mm 10 degrees, Part #326-07102610, nonsterile; (19) Calibrate CCX-S, 7 x 10 x 26mm 15 degrees, Part #326-07102615, nonsterile; (20) Calibrate CCX-S, 7 x 10 x 30mm 10 degrees, Part #326-07103010, nonsterile; (21) Calibrate CCX-S, 9 x 10 x 22mm 5 degrees, Part #326-09102205, nonsterile; (22) Calibrate CCX-S, 9 x 10 x 22mm 10 degrees, Part #326-09102210, nonsterile; (23) Calibrate CCX-S, 9 x 10 x 26mm 5 degrees, Part #326-09102605, nonsterile; (24) Calibrate CCX-S, 9 x 10 x 26mm 10 degrees, Part #326-09102610, nonsterile; and (25) Calibrate CCX-S, 11 x 10 x 26mm 10 degrees, Part #326-11102610, nonsterile. Convenience kits containing affected implants: (1) Calibrate CCX Oblique Implants, REF CLCCXOIMPA, containing 24 implants/kit, nonsterile; and (2) Calibrate CCX Straight Implants, REF CLCCXSIMPA, containing 36 implants/kit, nonsterile.

    FDA Enforcement
    Class II ·Ongoing·Alphatec Spine, Inc.·February 5, 2025

    BrightView, Gamma Camera System, Product Code 882480.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·January 17, 2024

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022