The Recall Desk

FDA (Devices) recall action 62271

Shimadzu Medical Systems recalled 6 products on 2012-11-14

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2012-11-14
Critical
0
Units
1,402

Why these products were recalled

Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–6 of 6

  • ModerateFDA (Devices)··2012-11-14

    Shimadzu Recalls Diagnostic X-Ray Beam-Limiting Devices for Performance Non-Compliance

    Shimadzu Medical Systems is recalling 665 R-30H Diagnostic X-Ray Beam-Limiting Devices because they may not comply with 2006 product performance standards regarding beam quality.

    Product
    R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-ray tubes 0.6/1.2P364DK-85, 0.6/1.2P324DK-125, 0.6/1.2P324DK-85, 0.6/1.2P38DE-85 Device Model # R-30H. Subsequent Product Code: IZX Product Usage: The device is the beam-limiting
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-11-14

    Shimadzu Recalls Mobile X-ray Systems for Beam Quality Non-Compliance

    Shimadzu Medical Systems is recalling 3 mobile X-ray systems because they may not meet federal beam quality standards.

    Product
    0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-11-14

    Shimadzu Recalls Mobile X-ray Systems for Beam Quality Non-Compliance

    Shimadzu is recalling 288 mobile X-ray systems and related components because they may not meet federal standards for beam quality.

    Product
    0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H. Classification Name: Mobile x-ray system. Device Model#MUX-100H. Product Usage: The device is a mobile X-ray system in order to take general radiography of
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-11-14

    Shimadzu Recalls Diagnostic X-Ray Beam-Limiting Devices for Performance Non-Compliance

    Shimadzu is recalling 308 R-20J Diagnostic X-Ray Beam-Limiting Devices because they may not meet 2006 FDA performance standards for beam quality.

    Product
    R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK-85, 0.6/1.2P324DK-125, 06/1.2P324DK-85, 0.6/1.2P38DE-85. Product Usage: The device is the beam-limiting device for X-ray Radiography.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-11-14

    Shimadzu Recalls Mobile X-ray Systems for Beam Quality Non-Compliance

    Shimadzu Medical Systems is recalling 5 mobile X-ray systems because they may not meet federal beam quality standards.

    Product
    0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-11-14

    Shimadzu Recalls Mobile X-ray Systems for Beam Quality Non-Compliance

    Shimadzu Medical Systems is recalling 133 mobile X-ray systems because certain units may not meet federal beam quality standards.

    Product
    0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
    Category
    Distribution
    0 states