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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:120442

Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing, or lying in the prone or supine positions. Not intended for mammography.

Official recall number

Z-1964-2013

Evidence summary

Product code
IZL
Recall status
Terminated
Event initiated
June 11, 2013
Root cause
Radiation Control for Health and Safety Act
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1964-2013

Field note

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