The Recall Desk

FDA (Devices) recall action 73504

Siemens Medical Solutions USA, Inc. recalled 2 products on 2016-04-06

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2016-04-06
Critical
0
Units
3,816

Why these products were recalled

We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-00002). The result of a Hazard Analysis and CAPA investigation, we have determined that for e.cam or Symbia E systems that although the existing user manual is correct, additional supplemental instructions, with the inclusion of visual aids, may further clarify and emphasize the proper collimator change

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.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2016-04-06

    Siemens E.CAM Gamma Camera Recall for Collimator Change Instructions

    Siemens is recalling 3,090 E.CAM gamma camera systems to provide supplemental instructions and visual aids for proper collimator changes.

    Product
    The E.CAM gamma camera system Product Usage: The E.CAM gamma camera system is a SPECT system and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body
    Category
    Distribution
    52 states
  • ModerateFDA (Devices)··2016-04-06

    Siemens Symbia Gamma Camera Recall for Collimator Change Instructions

    Siemens is recalling 726 Symbia gamma camera systems worldwide to provide supplemental instructions clarifying the proper collimator change procedure.

    Product
    The Symbia gamma camera system Product Usage: The Symbia gamma camera system is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same…
    Category
    Distribution
    52 states