Recall Z-0607-2012 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems
SKYLight Imaging Systems, Model 882050; Intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
| Date | Jan 11, 2012 (initiated Dec 8, 2011) |
| Status | Terminated |
| Reason | During preventative maintenance, a crack was discovered in the lower portion of the old style, non-common arm for the detector assembly, which could result in the detector dropping in an uncontrolled manner. |
| Root cause | Device Design |
| Action | Urgent Medical Device Correction/Field Safety Notices, dated Dec 08, 2011, were mailed to affected customer sites on December 9th and 12th, 2011 by Return Receipt certified mail. The letter identified the affected product, described the issue and when it could occur, along with the hazards involved. Customers were advised to stop using the system and contact a Philips service representative for an immediate inspection. Customers were also to follow the Instructions For Use to avoid the issue. Philips service will contact customers to arrange a time for Philips to inspect the system. The l |
| Quantity | 129 |
| Distribution | Worldwide Distribution -- USA, Canada, Italy, Spain, France, United Kingdom, Sweden, Switzerland, Germany, Japan, Denmark, and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000908 | SKYLIGHT IMAGING SYSTEM Adac Laboratories, Apr 5, 2000 |