Philips Medical Systems Sales & Service Region No. America OmniDiagnost System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OmniDiagnost System
Brand
Philips Medical Systems Sales & Service Region No. America
Lot Codes / Batch Numbers
OmniDiagnost User Interface PN 9896 000 59561, 9896 000 12381, 9896 000 58161, The firm utilizes a ''site number'' specific to each unit: 101599, 103055, 103058, 100520, 100873, 101152, 101154, 101676, 101962, 102164, 102582, 102977, 103050, 103051, 103052, 103055, 103058, 103218, 103219, 104012, 104577, 104858, 104934, 105324, 105394, 13124, 38351, 50428, 76596, 76944, 76948, 82655, 83871, 83958, 84441, 84850, 85163, 85165, 86113, 86303, 86326, 86339, 86340, 86485, 86486, 86549, 86965, 86977, 87164, X1707, X1747, 104857
Products Sold
OmniDiagnost User Interface PN 9896 000 59561, 9896 000 12381, 9896 000 58161; The firm utilizes a ''site number'' specific to each unit: 101599, 103055, 103058, 100520, 100873, 101152, 101154, 101676, 101962, 102164, 102582, 102977, 103050, 103051, 103052, 103055, 103058, 103218, 103219, 104012, 104577, 104858, 104934, 105324, 105394, 13124, 38351, 50428, 76596, 76944, 76948, 82655, 83871, 83958, 84441, 84850, 85163, 85165, 86113, 86303, 86326, 86339, 86340, 86485, 86486, 86549, 86965, 86977, 87164, X1707, X1747, 104857
Philips Medical Systems Sales & Service Region No. America is recalling OmniDiagnost System due to Labeling of push button caps located on the control panel may not clearly identify the applied Source to Image distance (SID).. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling of push button caps located on the control panel may not clearly identify the applied Source to Image distance (SID).
Recommended Action
Per FDA guidance
On 7/17/03 the firm issued a letter dated June 12, 2003 to their customers advising that service personnel will visit the consignees and replace the buttons.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026