Siemens Medical Solutions USA, Inc.

How does FDA spell Siemens Medical Solutions USA, Inc.?

FDA publishes this company under 18 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Showing 8 of 18.

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does Siemens Medical Solutions USA, Inc. file in?

77 product codes, ranked by how much they file in each.

Showing the 25 they file in most, of 77.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Has Siemens Medical Solutions USA, Inc. had a recall?

openFDA lists 1,245 recall records naming this company across its whole history, of which 35 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.

• Z-2648-2026Class IIOpen, ClassifiedOWB8 June 2026

  Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.

• Z-2641-2026Class IIOpen, ClassifiedOWB20 May 2026

  Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

• Z-2642-2026Class IIOpen, ClassifiedOWB20 May 2026

  Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

• Z-2643-2026Class IIOpen, ClassifiedOWB20 May 2026

  Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

• Z-1814-2026Class IIOpen, ClassifiedOWB12 March 2026

  During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.

Showing the 5 most recently initiated of 1,245.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved 2026-08-11T14:48:53Z

What has Siemens Medical Solutions USA, Inc. cleared recently?

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Where is Siemens Medical Solutions USA, Inc. registered?

FDA lists 5 registered establishments for this company in US.

Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.