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原文(Original)
國內有引進: 衛署醫器輸壹字第001537號 代理商是韶田公司
Recall Class: Class I
Date Recall Initiated: October 26, 2011
Product: OSI Modular Table Systems (including Modular Bases, Jackson Spinal, Imaging, Lateral, & Orthopedic Tops)
Manufacturing From: January 1992 - June 2011
Distribution From: January 1992 - June 2011
The affected models and lot numbers can be found below:
| Model | Product Name |
|---|---|
| 5803/5803I | Advanced Control Modular Base, 120VAC 60Hz or 230VAC 50/60Hz |
| 5890 | Retractable "I" Base - Manual tilt & lock functions |
| 5891 | Non-Retractable "I" Base - Manual tilt & lock functions |
| 5892 | Advanced Control Retractable "I" Base - electric powered tilt & lock |
| 5855 | Orthopedic Trauma Table Top |
| 5895 | Maximum Access Lateral Top |
| 5927 | Radiolucent Imaging Top with Tempur-Med |
| 5840-726 | Imaging Top w/ Tempur-med pad (part of Model 5827 System) |
| 5840-831 | Spinal Surgery Table Top (part of Jackson Spinal Surgery Top System) |
| 5943 | Jackson Spinal Table |
| 5843AP | Jackson Spinal Surgery Top w/Advanced Control Pad System 100/120VAC 50/60Hz |
| 5943API | Jackson Spinal Surgery Top w/Advanced Control Pad System 230VAC 50/60Hz |
| 5996/5996I | Advanced Control Pad System Variable Speed |
| 6977 | AXIS Jackson System with Advanced Control Pad System 100/230 VAC 50/60Hz |
Use: For patient positioning during a diverse set of orthopedic trauma, thoracic, and spinal surgery procedures.
Recalling Firm:
Mizuho Orthopedic Systems Inc
30031 Ahem Avenue
Union City, CA 94587
Reason for Recall: There are reports of injury related incidents while using Mizuho OSI Modular Table Systems. The incorrect removal of the T-pins that support the bottom base, instead of the T-pins that support the top, may result in the lower table top and patient falling to the floor. Another potential concern is unexpected movement/tilting of the table which may result in unanticipated movement and/or patient falls during surgery. Both of the above may result in serious injury or death.
Public Contact: Questions should be directed to Mizuho on their toll-free hotline at 1-800-777-4674, Monday through Friday from 9:00 am to 5 pm, Pacific Time
FDA District: San Francisco
FDA Comments:
On July 29, 2011, Mizuho, in recognition of past failure modes, issued a Field Advisory Notice to Hospital Risk Management, Operating Room Directors, Operating Room Technicians, Physicians, Nurses, Anesthesiologists and any personnel involved in the use and/or set up of the OSI Modular Table Systems. The Field Advisory Notice provided warnings and recommendations for safe use of the Mizuho OSI Modular Table Systems including performing a verification count of all the T-pins to confirm the stability of the table top.
While FDA agrees that the factors identified by the firm may have contributed to some reported failures, FDA is concerned that the firm has not identified all factors contributing to these events.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program1 either online, by regular mail or by FAX.
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