FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: Nuclear Magnetic Resonance Imaging System (MRI). Trace item 9896-030-14351 -1.5T Sense XL Torso coil 12nc on coil: 4535-671-4188x.
- Recall number
- Z-2461-2010
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- Nuclear Magnetic Resonance Imaging System (MRI). Trace item 9896-030-14351 -1.5T Sense XL Torso coil 12nc on coil: 4535-671-4188x.
- Status
- Terminated
- Initiated
- 2008-09-30
- Posted
- 2010-09-22
- Terminated
- 2010-09-30
- Reason
- The cables of the coil may become too hot and cause burns when placed too close to the patient. While using the 1.5T Sense XL Torso coil, unwanted radiofrequencies (RF) interaction with the patient can occur. Especially in combination with high SAR levels and when the RF cables of the coil are too close to the patient, this RF interaction has resulted in RF burns to patients.
- Root cause
- Other
- Action
- Philips Healthcare issued URGENT-Device Correction Notices dated September 30, 2008 to their consignees. The notice identified the recalled device as 1.5 Intera and 1.5T Achieva MRI systems, described the risk to patients, and the actions to be taken by customers.. The firm has issued Field Change Order (FCO) 78100242. Field service representatives will visit each consignee and conduct a hardware upgrade, applying a sleeve over the cable that will ensure proper spacing between the cable and patient, reducing the chance of RF interaction and burns. The consignees should contact the Philips Call Center at 1-800-772-9377, #5 #3, #1 and reference "FCO 78100242 - PATIENT CABLE SLEEVE FOR 1.5T SENSE XL TORSO COIL".
- Quantity
- 47 units total (Achieva 1.5T and Intera 1.5T)
- Distribution
- Nationwide Distribution: Throughout USA. No distribution to foreign consignees.
- Lot, serial or model codes
- Devices are identified as Site numbers: 544006, 537871, 534961, 544704, 545154, 545236, 545219, 545943, 546637, 545879, 545914, 543286, 547585, 548729, 550876, 553379, 550044, 554797, 41443789, 555412, 41444993, 41445232, 556803, 557348, 557344, 557513, 557179, 557644, 557560, 551656, 558845, 41446147, 552550, 552516, 555787, 41445636, 41455922, 83325, 558369, 86968, 101408, 101877, 102110, 102353, 102004, 104343, and 41455948.
- 510(k) numbers
- ["K052013"]
- PMA numbers
- not on file
- Product code
- MOS
- Firm FEI
- 1000524572
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28