FDA Device Recall Z-0033-2014: Philips Medical Systems (Cleveland) Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0033-2014.

Recall Res Number

Z-0033-2014

Recalling Firm / Manufacturer

Philips Medical Systems (Cleveland) Inc

FEI Number

1525965

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2013-08-07

Date Posted

2013-10-21

Date Terminated

2014-03-26

Product Code

LNH

Event Number

66312

Product Quantity

Total 511 (Asset 0.5T,: 35 units Apollo 0.5T: 15 units, Infinion 1.5T: 116 units, Eclipse/Polaris 1.5T: 290 units, Panorama 0.6T: 55 units)

Product Description Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.

Reason for Recall There is a potential for water to collect in the vent pipe elbow in the magnet venting system. Water may freeze, blocking the venting system.

Action Details Philips Healthcare sent an Urgent Medical Device Correction letter via certified mail on August 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information with all of their staff who need to be aware of the contents of this communication. Philips Healthcare will perform any necessary corrective actions prior to the customer's next cryogen refill. Customers with questions were instructed to contact their Philips field service representative: Technical Support Line 1-800-722-9377. For questions regarding this recall call 1-800-722-9377.

Distribution Pattern Worldwide Distribution - US (nationwide) including FL, CO, KY, MS, PA, NC, NJ, TX and Puerto Rico and internationally to Italy.

Code Information / Serial Numbers M/N: 781220, 781230, 781301, 78129 and 78127. Codes: AM128, 1510, 1518, BA318, AM120, ZA178, ZA196, ZA107, ZA133, ZA172, ZA158, BA149 and ZA208.

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Medical Device Recall: Z-0033-2014

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer