Reported May 30, 2018 · Terminated

ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the…

Getinge US Sales LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GETINGE US SALES LLC · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094

Is this the product you have?

  • ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient
  • Part Numbers
    • ARD567801093
    • ARD567801094
Lot codes and dates
  • Serial Nos.

    667 of 667 codes

    • ON000104
    • ON000104
    • ON000108
    • ON000108
    • ON000300
    • ON000302
    • ON002984
    • ON002986
    • ON002990
    • ON003002
    • ON003003
    • ON005382
    • ON005383
    • ON005432
    • ON005433
    • ON005434
    • ON005435
    • ON007749
    • ON007751
    • ON007762
    • ON007767
    • ON007769
    • ON007770
    • ON007771
    • ON007772
    • ON007773
    • ON007775
    • ON007776
    • ON007777
    • ON007778
    • ON009146
    • ON009147
    • ON009148
    • ON009149
    • ON009150
    • ON009151
    • ON009152
    • ON009153
    • ON009154
    • ON009155
    • ON009156
    • ON009157
    • ON009160
    • ON009162
    • ON009163
    • ON009164
    • ON009165
    • ON009166
    • ON009172
    • ON009173
    • ON009174
    • ON009178
    • ON009215
    • ON009216
    • ON009217
    • ON009218
    • ON009219
    • ON009234
    • ON009237
    • ON009239
Amount recalled
667

Why it was recalled

Getinge has received complaints concerning the X TEN Surgical Lights whose spring arms have broken, causing light heads to separate from the assembly. The issue relates to cracking of the spring arms at the weld seams that has the potential to develop into breaks with heavy use and aging of the equipment.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 21, 2021 · Data as of Sep 19, 6:50 PM UTC

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