Recall Z-1973-2011 ยท IXR Table, Radiographic, Tilting
Medical Positioning Inc
Rapid Response H.U.T. (Head Up Tilt) Table. Model 1017. Powered electrophysiology tilt table. Table can tilt -15 degrees to 90 degrees (Trendelenburg). Medical Positioning Incorporated.800-593-3246. Used in clinical and hospital settings by trained radiologists.
| Date | Apr 13, 2011 (initiated Feb 1, 2010) |
| Status | Terminated |
| Reason | The tilt tables work intermittently and some have become stuck in an inclined or reclined position during procedures. |
| Root cause | Other |
| Action | An undated Urgent - Voluntary Medical Device Product Correction letter was issued on 2/1/2010 by certified mail with return receipt requested. The letter identified the model and serial numbers of the affected product. The consignees were advised to stop using the table immediately and remove it from service until further notice. Customers were to contact Mr. Joe Hurtig at 1-800-593-3246 or jhurtig@medicalpositioning.com to confirm receipt of the notice and to provide the firm with the correct contact information. Individualized correction packages including replacement parts and instructi |
| Quantity | 58 total |
| Distribution | Worldwide Distribution -- USA, including Puerto Rico, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.