| Date Initiated by Firm | January 27, 2005 |
|---|
| Date Posted | May 17, 2005 |
|---|
| Recall Status1 |
Terminated 3 on February 20, 2014 |
| Recall Number | Z-0844-05 |
|---|
| Recall Event ID |
31050 |
| Product Classification |
System, Thermal Regulating - Product Code DWJ
|
| Product | Cool/Heat Versatility Main Controller Unit with 7-pin port only (for use with Thermal Resistive Type mattress) |
|---|
| Code Information |
Unit Serial Numbers 1020V0503E00174 1020V0304E00058 1020V0403E00145 1020V0203E00102 1020V0503E00088 1020V0403E00153 |
| FEI Number |
3003571190
|
Recalling Firm/
Manufacturer |
AMF Support Surfaces Inc
1691 N Delilah St
Corona CA 92879-1885
|
| For Additional Information Contact | Ken Siegner
951-549-6800 |
|---|
Manufacturer Reason
for Recall | Operator misconnected device power cords causing failure of the device. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Recall letters dated January 28, 2005, wee sent to consignees with instructions that a new control unit was being sent to their attention and directions for return of the previous control units. |
|---|
| Quantity in Commerce | 6 |
|---|
| Distribution | IN, MD, ND |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
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.
|
