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Recall Observatory FDA recall evidence

Device product

Artis zee floor, Material no. 10094135, for angiography and whole body radiographic/fluoroscopic procedures.

Z-2311-2018

May 01, 2018

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 80286
Status
Terminated
Classification
Class II
Quantity
14
Official record key
device-enforcement:Z-2311-2018

Official wording

Reason: After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.

Code information: 137165 137146 137311 137229 137231 137224 137217 136979 136557 136558 136391 136503 136594 136278

Distribution pattern: Worldwide distribution. US nationwide including Puerto Rico, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Luxembourg, Mexico, Myanmar, Netherlands, New Zealand, Norway, China, Paraguay, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.