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Health o meter Professional
Pelstar, LLC · Model YG500R · UDI-DI 00854896003641
10
510(k) clearances
115
Adverse events (4 deaths)
7
Recalls
98
Facilities
Description
Mechanical Diaper Scale
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-06-19 | Seca | It has been determined that the wheels on the baby scale cart can unexpectedly loosen and in the worst case, detach from the cart completely. If this occurs the cart can become uns |
| 2012-12-13 | Sr Instruments Inc | SR Instruments Inc. is implementing a field correction for the Joerns Healthcare Patient Lifts after they received two incident reports regarding two field failures of a tensile ty |
| 2007-12-19 | Arjo, Inc. | Unintended Hanger Bar Detachment: The locknut on the scales may loosen during use and allow the hanger bar assembly of the patient lift to detach and fall. |
| 2007-12-19 | Arjo, Inc. | Unintended Hanger Bar Detachment: The locknut on the scales may loosen during use and allow the hanger bar assembly of the patient lift to detach and fall. |
| 2007-06-13 | Liko, Inc. | Sling bar may have a center bolt break at the adapter while in use |
| 2007-06-13 | Liko, Inc. | Sling bar may have a center bolt break at the adapter while in use |
| 2007-01-30 | Integrated Measurement Systems, Inc. | Patient Scale may become detached, which can cause a patient to fall and result in injury. |
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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.
