Devices

Device Recall Carestream Touch Prime and Carestream Touch Prime XE

Model / Serial
Serial Numbers: US units: 106, 112, 114, 116, 1021, 1037, 1038, 1044, 1057, 1067, 1072, 1074, 1079, 1090; OUS units: 1005, 1006, 1009, 1011, 1015, 1017, 1018, 1020, 1031, 1041, 1042, 1043, 1045, 1081, 1086, 1089.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US including SC, GA, TX, OH, IA, NY and foreign distribution to Switzerland and Malaysia
Product Description
Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System || Diagnostic ultrasound imaging or fluid flow analysis of the human body
Manufacturer
Carestream Health Inc
1 Event
- Recall of Device Recall Carestream Touch Prime and Carestream Touch Prime XE

Manufacturer

Carestream Health Inc

Manufacturer Address
Carestream Health Inc, 150 Verona St, Rochester NY 14608-1733
Manufacturer Parent Company (2017)
ONEX Corp
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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