Siemens Syngo Imaging PACS Recalled for Potential Data Loss
Siemens is recalling 36 units of Syngo Imaging version V31 software due to a potential risk of data loss relevant to diagnosis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential for data loss relevant to diagnosis, which poses a risk of harm to patients if diagnostic information is lost, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 36 units of Syngo Imaging version V31 (model # 10014063). This software is a Picture Archiving and Communication System (PACS) used to display, process, read, report, communicate, distribute, store, and archive digital medical images, including digital mammography images. The system supports physicians in diagnosis and treatment planning.
The recall is being issued because Siemens is releasing a letter to inform customers about a potential for data loss relevant to diagnosis. The affected units were distributed nationwide in the United States to the states of MA, CA, NC, WI, NY, NE, PA, AL, NJ, MO, MI, TX, MS, KS, LA, CT, MD, CO, OK, MN, and TN.
The source text does not specify specific actions for consumers or healthcare providers beyond the notification letter. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. It supports the physician in d
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 36
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- material 10014063 Serial numbers: 1334
- 1065
- 1417
- 1043 1353
- 1491
- 1496
- 1316
- 1279
- 1116
- 1090
- 1081
- 1310
- 1226
- 1396
- 1107
- 1343
- 1198
- 1432
- 1058
- 1082 1055
Distribution
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