Recall Z-0181-04 ยท IOR Wheelchair, Mechanical
Bock,Otto,Orthopedic Ind,Inc
Otto Bock Kimba Plus Pediatric Tilt-in-Space Postural Mobility Systems (Strollers), Product Numbers HR32571001-012, HRK3269=06-027_X, R32651001-012, HRK3283=01-026_X, HRK3269=01-026_X, HRK3283=02-026_X, HRK3269=02-026_X, HRK3283=03-027_X, HRK3269=03-027_X, HRK3283=04-027_X, HRK3269=04-027_X, HRK3283=05-026_X, HRK3269=05-026_X, and HRK3283=06-027_X
| Date | Jul 20, 2004 (initiated Oct 29, 2003) |
| Status | Terminated |
| Reason | Under certain conditions the tilt mechanism of the strollers may not function properly allowing the child to fall out if the seat belt is not fastened. |
| Root cause | Other |
| Action | Recall letters dated October 23, 2003 were sent to the consignees on 10/29/03 and 10/30/03. The letters requested that the consignees contact the firm''s Customer Service Department to report the affected units they have. The letter states that the Customer Service Department will send the consignees the necessary field modification kits and instructions to correct the problem in the units they have and have located at their customers. |
| Distribution | The product was distributed nationwide in the United States and to Canada and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.