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EMSRUN
Wuxi Emsrun Technology Co., Ltd. · Model CR-S11 · UDI-DI 06974567741925
10
510(k) clearances
1,212
Adverse events
12
Recalls
129
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-06-29 | Winco Mfg., LLC | Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications. |
| 2016-06-29 | Winco Mfg., LLC | Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications. |
| 2016-06-29 | Winco Mfg., LLC | Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications. |
| 2011-10-31 | Stryker Medical Division of Stryker Corporation | The Foot Rest Kit may have the wrong pivot spacers making the joint more susceptible to relaxation and prone to fatigue. There is a moderate risk of injury to the patient should th |
| 2011-06-28 | Stryker Medical Division of Stryker Corporation | Some of the red release bars used during the time frame of 22 December 2010 through 31 January 2011 were reworked. The rework subjected the parts to excessive heat and as a result |
| 2011-06-28 | Stryker Medical Division of Stryker Corporation | This recall was initiated as the firm ascertained the supplier may have reworked some of the red release bars used during the time frame of 22 December 2010 through 31 January 201 |
| 2009-09-02 | Stryker Medical Div. of Stryker Corporation | The front of the handle may become detached from the chair, which could result in a patient fall or an operator injury. |
| 2009-09-02 | Stryker Medical Div. of Stryker Corporation | The front of the handle may become detached from the chair, which could result in a patient fall or an operator injury. |
| 2008-11-18 | Stryker Medical Div. of Stryker Corporation | Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay |
| 2008-11-18 | Stryker Medical Div. of Stryker Corporation | Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay |
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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.