Recall Z-1207-06 ยท INT Plinth
SAMMONS PRESTON ROLYAN
ValueLine Mat Platform Model C2230A,B,C; C922-30A, B,and C; C6904, C6903, C6902, C6901. All tables have the standard platform and the model numbers represent the additional shelves or drawers and the arrangement.
| Date | Jul 12, 2006 (initiated Jan 25, 2006) |
| Status | Terminated |
| Reason | There have been reports of structural failure on the skirt of select tables. The risk to patients presented by possible structural failure of the skirt of the table is a slow collapse of the plinth which could cause the patient to be displaced. |
| Root cause | Other |
| Action | Letters were sent to customers certified mail on 1/25-26/2006 instructing them to take the tables out of service until it could be inspected by a sales representative. Sales represenatives are following up with customers in person to inspect tables. |
| Quantity | 561 devices total |
| Distribution | Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.