CLASS II Device recall · Reported 3 Jun 2015 · FDA Enforcement Report

Siemens Ysio Max recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Siemens Ysio Max, distributed nationwide in the US. The recall was initiated on 13 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number of device 10762470, with serial numbers: 24077 24051 24038 24116 24082 24033 24136 24155 24159 24066 24106 24052 24128 24059 24048 24099 24100 24028 24046 24063 24083 24135 24131 24091 24024 24129 24103 24148 24142 24014 24015 24026 24109 24034 24108 24049 24058 24113 24154 24156 24039 24081 24114 24090 24105 24075 24016 24025 24042 24037 24053 24121 24087

Quantity recalled133 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1667-2015
FDA event ID: 71115
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 13 Apr 2015
FDA classified: 23 May 2015
Reported: 3 Jun 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

13 Apr 2015	Recall initiated by company
23 May 2015	Classified by FDA	+40 days
3 Jun 2015	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD subtask card or previous series button on the Image subtask card during image readout. Sporadically, during an automatic or a manual RIS update.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Is Siemens Ysio Max recalled?

Yes. Siemens Medical Solutions USA recalled Siemens Ysio Max on 13 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-1667-2015.

Why was it recalled?

Which lots are affected?

Model Number of device 10762470, with serial numbers: 24077 24051 24038 24116 24082 24033 24136 24155 24159 24066 24106 24052 24128 24059 24048 24099 24100 24028 24046 24063 24083 24135 24131 24091 24024 24129 24103 24148 24142 24014 24015 24026 24109 24034 24108 24049 24058 24113 24154 24156 24039 24081 24114 24090 24105 24075 24016 24025 24042 24037 24053 24121 24087

Where was it sold?

Nationwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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