Recall Z-1551-2011 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems
SKYLight 8 FT 3/8" SPECT; 9 FT 3/8", SPECT; 8 FT, 5/8" SPECT; and 9 FT 5/8" SPECT. Philips Medical Systems Intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
| Date | Mar 4, 2011 (initiated Dec 28, 2010) |
| Status | Terminated |
| Reason | Philips Healthcare Nuclear Medicine determined that the detector arm assembly could be compromised. |
| Root cause | Other |
| Action | Urgent - Medical Device Correction notifications were sent to all domestic consignees on December 28, 2010 via Federal Express. The letter identified the affected products, the reason for the recall, the hazard involved, and actions to be taken by the customer/user. Customers have been instructed to immediately stop using the system and contact a Philips service representative for an immediate inspection if one of the listed reasons apply. Customers were also instructed to follow the instructions in the system's Instructions For Use to avoid a collision or force on the detector. The firm's |
| Quantity | 540 units total, all varieties. |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000908 | SKYLIGHT IMAGING SYSTEM Adac Laboratories, Apr 5, 2000 |