| URGENT NOTICE FDA #Z-589-4
Burton Medical Products has Announced an IMPORTANT Safety Correction Program for Outpatient® and CoolSpot™ Series Single Ceiling or Single Fastrac Mounts Manufactured Between January 1, 1992 and July 31, 2000.(Footnote1)
Due to an inherent weakness in the original composition of the pivot support casting, the switch assembly and extension arm for your Outpatient®/CoolSpot™ Fleximounts listed on Attachment A should be replaced to prevent any risk of the light falling or separating from the ceiling mount.
IN KEEPING WITH OUR HIGH QUALITY STANDARD, BURTON IS OFFERING CUSTOMERS USING PRODUCTS COVERED BY THIS SAFETY ALERT A CHOICE OF EITHER A FREE PIVOT ASSEMBLY OR SIGNIFICANT SAVINGS FOR TRADE-IN ON A NEW LIGHT
| To insure that your facility complies with our Safety Alert, please: |
| (a) |
Review the drawing on Attachment A (to see if your lights appear to be the models covered by this program); |
| (b) |
Review the offer in Section I below; |
| (c) |
Complete and return Section II below (Response/Redemption Request*) within 30 days. |
SECTION 1
Free Pivot and Extension Arm
- or -
“Reagan Era” Pricing + Fantastic Warranty
for Trade-In of Your Light Covered by Safety Alert
(Save between $1095 and $1335 off retail)
| Includes: |
| • |
$1200 for Complete NEW Outpatient® II Single Ceiling Light
(Retail Value: $2,295) with Trade-In, (Footnote 2) Or |
| • |
$1,335 for Complete NEW CoolSpot™ II Single Ceiling Light
(Retail Value: $2,670) with Trade-In, (Footnote 2) Plus |
| • |
Five Year Warranty!! |
|
__________________________
Footnotes:
| 1 See complete part number information for units affected by this Safety Alert on (Attachment A) |
| • |
Units manufactured after July 2000 are not subject to this safety replacement notice. Pivot support-switch assemblies manufactured after July 2000 incorporate a single machined pivot that inherently limits the risk of the light heads separating from the ceiling mount. |
| • |
Double Outpatient®/CoolSpot™ mounts are not subject to this safety replacement notice due to their pivot assembly design that inherently limits the rotation of the light heads and prevents separation from the ceiling mount. |
2 To qualify for Safety Alert Trade-In you must return the original pivot assembly and complete additional paperwork. The sale of the new Outpatient® II/CoolSpot™ II light will be arranged through an Authorized Burton Dealer.
SECTION 2
 |
 |
Response/Redemption Request Form |
Outpatient II CoolSpot II
Trade-in Application |
|
