Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
Enforcement
- Recall Number
- Z-2794-2016
- Event ID
- 75125
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 21, 2016
- Initiation Date
- August 2, 2016
- Classification Date
- September 14, 2016
- Termination Date
- March 20, 2017
- Address
- 40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States
Description
Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and indicates that a shown measurement value may be different from the real value.
Model Numbers: 10863171, 10863172, 10863173, 10592457 Serial Numbers: 100262,100389,100198,100258,100259,100538,100135,100133,100213,100214,100031,100032,100484,100362,100233,100140,100141,100142,100143,100144,100416,100105,100106,100109,100110,100111,100112,100113,100114,100115,100116,100117,100119,100120,100461,100457,100245,100447,100364,100314,100298,100299,100386,200277,100139,100027,100028,100300,100559,100440,100441,100197,100170,100025,100026,100084,100186,100189,100190,100191,100192,100195,100196,100550,100033,100034,100306,100307,100232,100449,100450,100185,100596,100256,100199,100188,100193,100194,100257,100226,100228,100425,100029,100030,100253,100203,100204,100132,100247,100248,100434,100215,100491,100495,100230,100221,100212,100539,100206
Nationwide Distribution
101 Systems