Recall Z-1701-2014 ยท IZH System, X-Ray, Mammographic
Hologic, Inc.
Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.
| Date | Jun 3, 2014 (initiated May 13, 2014) |
| Status | Terminated |
| Reason | Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury |
| Root cause | Component change control |
| Action | Hologic notified customers by letter dated 5/13/14 via certified mail or Federal Express to inform customers of the problem and provide acknowledgement of the notification and confirmation that their systems have been corrected A Dealer notification dated 5/13/14 sent by certified mail or Federal Express to inform Dealers of the need to notify their customers of the problem and to correct the identified Selenia system using Hologic Technical Bulletin TB-00806. On 5/16/14 the firm expanded the recall to an additional units Mammography System M-IV (2 units) and Selenia Mammography Systems (4) |
| Quantity | 3 units |
| Distribution | Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011987 | MODIFIED M-IV MAMMOGRAPHY SYSTEM Lorad, A Hologic Co., Jul 11, 2001 |