Gamma camera systems: AXIS SPECT Systems & IRIX SPECT Systems, Model #: AXIS- 882130, IRIX- 882140. Philips Healthcare.

FDA device recall Z-0988-2012 · posted 2012-02-10 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

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.

Action taken

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

Status

Terminated

Product code

KPS

Quantity affected

795 units

Distribution

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, P

Date initiated

2011-11-18

Date posted

2012-02-10

Date terminated

2013-02-22

Location

Cleveland, OH

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