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Parasol Patient Fall Prevention System
Parasol Medical, LLC · Model SC6S3 · UDI-DI 00854636006291
10
510(k) clearances
3,238
Adverse events (80 deaths)
32
Recalls
98
Facilities
Description
30 Day Chair Pad with 3 Foot Cord
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-02-14 | Hill-Rom Inc. | There is a software issue which may result in failure to monitor or control patient's bed exit mechanism. |
| 2018-10-11 | Stanley Security Solutions Inc | Damaged capacitor on the printed circuit board. |
| 2014-12-10 | Richard Wolf Medical Instruments Corp. | The transformers installed on carts used for Richard Wolf medical video systems may overheat causing smoke and black plastic material to leak from the cart chassis. |
| 2014-08-05 | Curbell Medical, Inc. | The firm became aware of a potential problem that was initiated by a customer complaint. After consultation with the manufacturer, it was discovered that a resistor was incorrectl |
| 2013-05-17 | RF Technologies, Inc. | RF Technologies, Inc. has initiated a recall involving CA520 Code Alert Integrated Care Management Advanced 4-Way Care Solution . Due to a firmware error, the alarm may not be tra |
| 2012-12-16 | Intel-GE Care Innovations LLC | Care Innovations detected a software anomaly: During the engineering investigation into the cause of why a Wander Alert was not generated, a defect in the implementation of the Wan |
| 2012-05-04 | Stanley Security Solutions, Inc. | The monitor may fail to sound an alarm |
| 2012-05-04 | Stanley Security Solutions, Inc. | The monitor may fail to sound an alarm |
| 2012-05-04 | Stanley Security Solutions, Inc. | The monitor may fail to sound an alarm |
| 2012-05-04 | Stanley Security Solutions, Inc. | The monitor may fail to sound an alarm |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.