Terminated

Gamma camera systems: AXIS SPECT Systems & IRIX SPECT Systems, Model #: AXIS- 882130, IRIX- 882140. Philips Healthcare. Used to do nuclear medicine diagnostic imaging of various body organs.

FDA Recall Z-0988-2012 · Posted 2012-02-10

Recalling FirmPhilips Medical Systems (Cleveland) Inc

Recall StatusTerminated

Product CodeKPS

Date Initiated2011-11-18

Date Terminated2013-02-22

Product Quantity795 units

Reason for Recall

Philips was informed that the detector buckets may experience weakness over time. As a result, this could cause the detector bucket to separate from the mounting plate of the gantry and eventually result in the detector falling.

Firm Action

On 11/15/2011 Philips sent Urgent - Medical Device Correction letters to their customers. The letters identified the affected product, the problem, the hazard involved, and the actions to be taken by users and the Philips. Customers are to place the letter in their User Documentation. Philips service will arrange a time to inspect customers' systems and conduct the appropriate field safety correction. Customers are to contact their local Philips representative if they need further support or information. In the US and Canada, customers can contact Philips Healthcare Customer Care Solutions Center at 1-800-722-9377.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution -- USA, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PRO, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY and the territory of Puerto Rico; and countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Egypt, Finland, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, & United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K964712PRISM XPVT SYSTEM (210823)Philips Medical Systems (Cleveland), Inc. · 1997-02-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.