FDA (Devices) recall action 71712
The FDA (Devices) publishes a recall like this one as 8 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 8 pages.
Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.
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.
Siemens is recalling one Biograph mCT S(40)-4R unit because it may be missing a locking ring on the optional ceiling mount.
Siemens Medical Solutions is recalling specific CT systems because optional ceiling mounts may be missing a locking ring.
Siemens Medical Solutions USA Inc. is recalling two Biograph 64-4R CT systems because they may be missing a locking ring on optional ceiling mounts.
Siemens Medical Solutions is recalling two Biograph mCT X-4R systems because they may be missing a locking ring on optional ceiling mounts.
Siemens Medical Solutions is recalling specific Biograph 6-4R CT systems because they may be missing a locking ring on optional ceiling mounts.
Siemens Medical Solutions is recalling three Biograph mCT Flow Edge-4R systems because they may be missing a locking ring on optional ceiling mounts.
Siemens Medical Solutions is recalling Biograph 64-3R TruePoint systems because they may be missing a locking ring on optional ceiling mounts.
Siemens Medical Solutions USA Inc. is recalling one Biograph mCT S(64)-4R unit because it may be missing a locking ring on the optional ceiling mount.