Z-1488-04

NT Intera Magnetic Resonance Image System

Name: Z-1488-04 NT Intera Magnetic Resonance Image System
Creator: Philips Medical Systems Sales & Service Region No. America
Published: 2004-08-20
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2004-08-20 / Terminated

FDA source

Philips Medical Systems Sales & Service Region No. America began a recall of NT Intera Magnetic Resonance Image System on 2004-08-20. The reason FDA records is "Potential for patient burn". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1488-04
Status: Terminated
Initiated: 2004-08-20
Posted: 2004-09-29
Terminated: 2006-02-09
Recalling firm: Philips North America LLC
Product: NT Intera Magnetic Resonance Image System
Product code: KRP Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal
Reason for recall: Potential for patient burn
FDA root cause: Other
Action: On 8/20/04 the firm issued a letter, via certified return receipt. The letter warned of the potential for patient discomfort and burns. An addendum providing additional information regarding cable positioning was included with the letter.
Quantity in commerce: 156 devices
Distribution: Units distributed to medial facilities and hospitals throughout the U.S.
Product codes and lots: Part #s 9896 030 09981, 9896 030 10251 Site #s 504531, 104343, 59488, 41391, 37996, 37979, 85119, 26269, 59435, X1281, 504409, 102353, 13606, 103166, 37929, 104392, 103149, 84418, 6947, 63046, 86293, 102978, 103904, 105315, 504866, X0038, 103582, 100745, 101946, 103333, 504412, 13056, 100786, 59428, 103818, 105314, 50430, 104808, 85139, 45016, X0716, X0942, X1272, X1086, X0214, 103324, 101420, 103579, 103847, 6808, 104467, 38652, 103347, 14117, 86335, 68196, 104032, 103417, 103243, 103207, 104102, 52408, 6841, 47029, 41346, 45065, X0164, X1082, 104912, X0083, 104054, 83325, 103911, 101477, 250156, 25958, 104193, 102547, 85172, 104897, 104070, 506190, 103946, 504608, 104340, 100462, 505007, 101595, 104095, 13932, 87527, 38966, 87604, 50336, 86085, 103291, 103592, 103098, 38257, 104532, 101162, 504897, 87018, 104336, X1693, 59637, 103143, 102933, 505021, 103631, 103552, 82678, X1635, X0162, 14065, 103530, 505568, 500034, 250498, 103099, 38438, 76359, 104138, 101561, 101560, 47043, 17394, 105271, X1215, 13057, 250475, 102569, 103770, 86313, X1179, X1523, 504632, 504527, X1412, 104942, 38317, 103101, 26119, 103509, 103544, 85433, 103547, 250122, 102896, 85158, 41342, 86012, 103907, 103909, 101408, 38420

Product code KRP

K001796Class IIGyroscan Intera (R7.5)Philips Medical Systems North America, Inc. / cleared 2000-09-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)