Recall Z-1607-2015 ยท LMC Camera, Multi Format, Radiological
Philips Medical Systems (Cleveland) Inc
Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.
| Date | May 13, 2015 (initiated Mar 11, 2015) |
| Status | Terminated |
| Reason | The firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet were misaligned. |
| Root cause | Device Design |
| Action | Philips sent an Urgent - Medical Device Correction letter dated March 12, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm requested their customers to do the following: " If a misalignment on the top and/or bottom of the guide rail between the cabinet and carriage can be visually detected do not continue with the collimator exchange procedure, " If the misalignment is visually detected, be aware that the customer/user cannot remedy this issue and will require service interaction prior to the continued |
| Quantity | 975 units |
| Distribution | Worldwide Distribution - US (nationwide) to the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY., and to the countries of : Australia, Austria |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.