Philips Medical Systems Sales & Service Region No. America Diagnost 97 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Diagnost 97
Brand
Philips Medical Systems Sales & Service Region No. America
Lot Codes / Batch Numbers
Diagnost 97 system code 708023, 70852, 70853, 70855, 70859. The firm utilizes a ''site number'' specific to each unit: 13608, 17605, 37995, 38897, 40940, 47166, 59633, 62936, 62937, 6935, 6981, 74057, 13709, 17436, 35481, 59497, 62885, 74056, 76345, 13951, 13971, 38500, 38530, 38657, 41372, 45013, 45014, 62988, 6993, X0668, X1069, X1207, 6852, 62504, 38023, 62666, 62667, 6853
Products Sold
Diagnost 97 system code 708023, 70852, 70853, 70855, 70859. The firm utilizes a ''site number'' specific to each unit: 13608, 17605, 37995, 38897, 40940, 47166, 59633, 62936, 62937, 6935, 6981, 74057, 13709, 17436, 35481, 59497, 62885, 74056, 76345, 13951, 13971, 38500, 38530, 38657, 41372, 45013, 45014, 62988, 6993, X0668, X1069, X1207, 6852, 62504, 38023, 62666, 62667, 6853
Philips Medical Systems Sales & Service Region No. America is recalling Diagnost 97 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