MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
Reported: November 18, 2015 Initiated: September 24, 2015 #Z-0265-2016
Product Description
MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
Reason for Recall
Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 15
- Distribution
- Distributed in PR and the states of MO, NC, GA, MS, LA, and KY.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 15.
Why was this product recalled? ▼
Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 18, 2015. Severity: Moderate. Recall number: Z-0265-2016.
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