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- Performa Tm-300 User's Manual Download
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| 510(k) | | DeNovo | | Registration & Listing | | Adverse Events | | Recalls | | PMA | | HDE | | Classification | | Standards |
| CFR Title 21 | | Radiation-Emitting Products | | X-Ray Assembler | | Medsun Reports | | CLIA | | TPLC |
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| New Search | Back to Search Results |
| | Class 3 Device Recall Performa TM300 Traction System |
| Date Initiated by Firm | July 13, 2005 |
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| Date Posted | August 31, 2005 |
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| Recall Status1 | Terminated 3 on January 09, 2008 |
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| Z-1444-05 |
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| | Recall Event ID | 31492 |
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| K992545 |
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| Apparatus, Traction, Non-Powered - Product CodeHST
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| | Product | TM-300 Traction System; an Rx software driven device used for patient traction; Manufactured for Sammons Preston Roylan, An Ability One Company, Bolingbrook, IL 60440, Manufactured by: ITO Co., Ltd., 3-3-3 Toyotama-Minami, Nerima-ku, Tokyo, 176-8605, Japan |
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| Code Information | Product No. A501-009, serial numbers 1000 through 1207 |
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Recalling Firm/ Manufacturer | Sammons Preston Rolyan, An Ability One Company 4 Sammons Ct Bolingbrook IL 60440-4995
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| For Additional Information Contact | Mr. Steve Armstrong 651-686-1769 |
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| The traction device may malfunction, producing oscillation and a jerking motion. |
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| Other |
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| Sammons Preston Roylan, the U.S. agent for Ito Co., Ltd. issued recall letters dated 7/13/05 to all of their customers who purchased the Performa TM-300 traction unit, informing them that the manufacturer, Ito Co., Ltd., is recalling the units because the units may exhibit oscillation during some traction modes. The accounts were requested to contact Tina Kreisher at 1-800-323-5547, ext. 1383 if their TM-300 unit has a serial number that falls in the range listed in the recall letter. Tina will arrange for the unit to be shipped to the manufacturer's authorized repair center for upgrading of the software to version 2.8, and for the shipment of a loaner unit while their unit is being upgraded. |
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| 208 units |
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| Nationwide and internationally to Canada, the United Kingdom, Korea, Turkey and Indonesia |
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| TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55. |
| 510(K) Database | 510(K)s with Product Code = HST and Original Applicant = ITO CO., LTD.
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