Precedence SPECT/CT System, Precedence 16 3/8, Upper Patient Pallet, A single photon nuclear medicine and image from an

FDA device recall Z-0897-2011 · posted 2011-01-12 · Terminated

Recall details

Recalling firm

Phillips Nuclear Medicine

Reason for recall

A problem has been identified with some upper patient pallets on Precedence SPECT/CT System, which may reduce its load bearing capacity and may result in its cracking. If this were to happens, could pose a risk to patient.

Action taken

The firm, Philips Healthcare, sent an "Urgent - Field Safety Notice" dated January 26, 2009 to all consignees/customers. The notice described the product, problem and action to be taken by customers and by Philips. The customers were instructed to reference their system's System Operation and System information Manuals regarding loading and unloading of patient; monitoring the patient during a study ,and careful monitoring during unsupported (cantilevered) table translation. Philips has ordered replacement parts and they will have a Philip Healthcare Field Service Engineer contact and visit the customers site within two months to replace the affected upper patient pallet. If you need any further information or support concerning this issue, please contact your local Philips representative at: Customer Care Center (1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: and Oncology or your local Philips Healthcare office.

Root cause

Process change control

Status

Terminated

Product code

INQ

Quantity affected

2 units

Distribution

International distribution only: Mexico and Saudi Arabia.

Date initiated

2009-01-26

Date posted

2011-01-12

Date terminated

2011-01-13

Location

Milpitas, CA

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