Artis Q ceiling, Material no. 10848281, for angiography and whole body radiographic/fluoroscopic procedures.
Reported: July 4, 2018 Initiated: May 1, 2018 #Z-2304-2018
Product Description
Artis Q ceiling, Material no. 10848281, for angiography and whole body radiographic/fluoroscopic procedures.
Reason for Recall
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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 5
- Distribution
- 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.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Artis Q ceiling, Material no. 10848281, for angiography and whole body radiographic/fluoroscopic procedures.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 5.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 4, 2018. Severity: Moderate. Recall number: Z-2304-2018.
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