Z-1667-2015Class II

SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables...

Name: Z-1667-2015 SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables...
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-04-13
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-04-13 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole... on 2015-04-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1667-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-13
Posted: 2015-05-23
Terminated: 2017-03-20
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: 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.
Product code: KPR System, X-Ray, Stationary
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.
Root cause tag: software
FDA root cause: Software design
Action: A safety advisory notice, dated April 13, 2015, was sent to end users with affected devices to alert them about the issue and associated risks,and to provide instructions for avoiding potential risk. A new software version will be released to permanently resolve the issue.
Quantity in commerce: 133 total
Distribution: Nationwide Distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1667-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1667-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-23
Z-1668-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-23
Z-1669-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-23
Z-1670-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-23

Product code KPR

K133259Class IIYsio MaxSiemens Medical Solutions USA, Inc. / cleared 2014-01-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)