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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67957

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 01, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Siemens Medical Solutions USA, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer.

Z-1645-2014
Recall number
Z-1645-2014
Initiated
April 01, 2014
Classification
Class II
Status
Terminated
Quantity
120

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Table may lose calibration during patient treatment, which may cause the possibility of mistreatment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Table may lose calibration during patient treatment, which may cause the possibility of mistreatment.

Code information

material #8139789 , 5857912, 7360717, 1940035, 8139789, 4504200, 5863472, serial # 5377, 5087, 70-4262, 5170, 5282 5506 3287 5527 5517 70-4378 3695 5364 5060 5205 5688 5743 70-4283 5190 5157 5343 5844 5148 5391 5300 70-4296 5474 70-4363 70-4368 3793 3817 5833 5899 5207 5355 70-4159 3524 5281 5894 5374 5558 3631 3835 5784 2765 5367 70-4354 70-4356 5540 5488 5590 5657 5350 5821 3413 5222 5843 5179 70-4129 5851 5098 5153 5700 5410 3825 5865 5118 5548 3769 5861 70-4188 5748 70-4317 5737 5830 5385 5656 3778 5088 5665 5823 5353 5630 5480 5096 5572 3873 5417 4059 5500 5388 70-4379 5226 5601 5640 5033 5177 5707 5398 4091 5532 70-4306 70-4161 5424 5755 5326 5145 5699 4079 4082 70-4077 70-4113 5525 5419 3975 5093 5481 5396 3089 5095 5154

Distribution pattern

USA ( nationwide) Distribution.