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Fischer Imaging Corp.

United StatesFDA applicant, unverified

Devices
69
FDA recalls
11

Catalogue69

Newest first, rows 51-69 of 69

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  • Da-100HS Ref K894913

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Three Phase Diagnostic X-Ray Generator Micro-X 100 Ref K880524

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Ceiling Mounted Fluoroscopic C-Arm Ariel C-Arm Ref K880527

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Csp Ref K912448

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Storz Imaging System Ref K915199

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • 3 Phase High Freq. Diag. X-Ray Gen. Micro-X 60HF Ref K880525

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Cardiac Cx Ref K883985

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Overhead Tube Mount Cascade Ii Ref K880528

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Mobile C-Arm Omni 325 Ref K880518

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Micro X-80 Hf Ref K944149

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Digital 625HF Ref K950291

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Fischer Imaging FX325R X-Ray Generator Ref K860736

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Micro-X 50 Hf Ref K914236

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Md-1835 Ref K964806

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Micro-X 100CP Ref K884134

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Ceiling Mounted Tilting Table Tangent Iii Ref K880529

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Micro X-30HF Ref K944148

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Single Phase Diag. X-Ray Generator Micro-X 650 Ref K880519

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Single Phase Diagnostic X-Ray Generator Fx 350 Ref K880532

    Active Regimes: 510(k) Registry: 510(k) Class:I

Rows 51-69 of 69

Showing 51-69 of 69

FDA recalls11

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Showing the 10 most recent of 11 recalls.

  • 2006

    • 27 Mar 2006 Z-0757-06 Unclassified (pre-2012) Terminated Software upgrade to preclude lost images during mammography procedure. Distribution: Nationwide. AZ, CA, CO, FL, GA, IL, IN, KS, MA, MI, MN, MT, NY, OK, SC, TX, WA, WI, WV. No government or military…
      Full distribution text Nationwide. AZ, CA, CO, FL, GA, IL, IN, KS, MA, MI, MN, MT, NY, OK, SC, TX, WA, WI, WV. No government or military consignees.
      Submission number: P010017S007

  • 2005

    • 28 Apr 2005 Z-1524-05 Unclassified (pre-2012) Terminated Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient. Distribution: Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military…
      Full distribution text Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military distribution.
      Submission numbers: K912448, K934481, K961207
    • 28 Apr 2005 Z-1525-05 Unclassified (pre-2012) Terminated Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient. Distribution: Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military…
      Full distribution text Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military distribution.
      Submission numbers: K912448, K934481, K961207
    • 28 Apr 2005 Z-1526-05 Unclassified (pre-2012) Terminated Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient. Distribution: Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military…
      Full distribution text Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military distribution.
      Submission numbers: K912448, K934481, K961207
    • 28 Apr 2005 Z-1527-05 Unclassified (pre-2012) Terminated Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient. Distribution: Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military…
      Full distribution text Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military distribution.
    • 13 Jan 2005 Z-0713-05 Unclassified (pre-2012) Terminated Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients. Distribution: Nationwide. Foreign distribution: Canada, Australia, Ireland, Italy, Japan, Malaysia, Switzerland, Netherlands, United…
      Full distribution text Nationwide. Foreign distribution: Canada, Australia, Ireland, Italy, Japan, Malaysia, Switzerland, Netherlands, United Kingdom.
      Submission number: K991293

  • 2004

    • 30 Sep 2004 Z-0787-05 Unclassified (pre-2012) Terminated Some VersaRad Systems have a faulty weld that may result in oil leakage. Distribution: Domestic distribution: ... International distribution: Germany, Greece, Italy, Kuwait, Spain, Sweden, Switzerland. No VA…
      Full distribution text Domestic distribution: ... International distribution: Germany, Greece, Italy, Kuwait, Spain, Sweden, Switzerland. No VA or military facilities.
      Submission number: K880530
    • 9 Jul 2004 Z-0379-05 Unclassified (pre-2012) Terminated X-ray tube actuator shaft may fail, allowing the mechanism to drop without warning. Distribution: Nationwide, including VA facility in AR, military facilities in CA, FL, GA, MD, MO, NC, TX. Foreign distribution to…
      Full distribution text Nationwide, including VA facility in AR, military facilities in CA, FL, GA, MD, MO, NC, TX. Foreign distribution to Austria, Belgium, Canada, Czech Republic, France, Germany, Greece, Italy, Norway, Poland, Portugal, Russia, Saudi Arabia, Spain, Switzerland, The Netherlands, UK.
      Submission number: K861692
    • 21 May 2004 Z-1094-04 Unclassified (pre-2012) Terminated Existing software may allow Image data to be truncated in the margin of the breast on processed patient images. Distribution: FL, NC, NY, OK, WI. Foreign distribution to France. Submission number: P010017
    • 23 Apr 2004 Z-0974-04 Unclassified (pre-2012) Terminated If two of the four T-nuts that connect the transverse rail to the ceiling rail fail, the 'U' arm and transverse rails could fall and cause serious injury. Distribution: Nationwide, including VA facilities in MI, MN and VT. No military consignees. Foreign distribution to Australia, Canada,…
      Full distribution text Nationwide, including VA facilities in MI, MN and VT. No military consignees. Foreign distribution to Australia, Canada, Denmark, Italy, Korea, Netherlands, Norway, Sweden, United Kingdom.
      Submission number: K880530
Show all 11 recalls

  • 2004

    • 12 Apr 2004 Z-0939-04 Unclassified (pre-2012) Terminated X-ray tube may overheat after high usage because of mis-wired thermal switch circuit. Distribution: Nationwide CA, CO, FL, IN, MA, MO, NC, NY, OK, TX, WI, Mexico, France. No government or military distribution. Submission number: P010017