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Terminated

3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #SNBSM-0048.

FDA Recall Z-1236-04 · Posted 2004-07-30

Recalling FirmDaavlin Distributing Company
Recall StatusTerminated
Product CodeFTC
Date Initiated2003-09-01
Date Terminated2007-07-24
Product Quantity23 units distributed domestically and 23 units distributed to foreign accounts.

Reason for Recall

Software errors cause the unit to not deliver the prescribed therapy and do not allow the patient records to be saved.

Firm Action

The firm has software patches to correct the programming problems as they are reported by the users. These patches are being installed either by a service representative for the manufacturer or by the customer

Root Cause

Other

Distribution Pattern

Nation wide plus Canada, the Philippines, Saudi Arabia, Turkey & Germany

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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